Coronary Heart DiseaseNCT06640400
Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI
A study testing Cardiovascular ultrasound in people with Coronary Heart Disease, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Cardiovascular ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age of enrollment at least 18 years 2. Patients with confirmed coronary artery disease requiring elective PCI 3. TIMI flow grade 2 or above after PCI 4. No intraoperative complications of PCI such as entrapment, reflux, or perforation of coronary artery.
- 5. The skin in the anterior chest area is intact and not broken. 6. Cardiac enzymes and troponin I are within normal range before enrollment. Exclusion Criteria
- Patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction.
- Occlusion of branch vessels during PCI.
- Patients with perioperative use of hormones or immunosuppressants
- Combined infection or other inflammatory diseases
Show all 15Show fewer
- Postoperative fever
- Patients are allergic to contrast media or cardiovascular ultrasound acoustic head-related materials.
- Changes in lipid-lowering, antiplatelet, and antihypertensive drug regimens during treatment.
- Patients with a clear diagnosis of autoimmune disease
- Patients who have undergone other surgeries in the past 7 days or have a history of trauma.
- Patients infected with novel coronavirus in the past month.
- Previous PCI treatment
- Previous cardiovascular ultrasound treatment
- Diabetic patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Jinnan, Shandong, 250000
Lin Shen, MD, 086 18560088219, slmm321@126.com
Chunwei He, MD, 08617361616499, hechw160814@163.com
About this study
Official title: A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease
The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are:
Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI.
Read more
Participants will:
Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days.
Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3.
Their symptoms were recorded, and depression and anxiety were scored.
Read the detailed description
Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking.
Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software.
Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.
- Conditions
- Coronary Heart Disease
- Being tested
- Cardiovascular ultrasound
- Keywords
- cardiovascular ultrasound, PCI, rehabilitation, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular ultrasoundDevice
Participants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart\'s long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group received cardiovascular ultrasound plus conventional drug therapy. Receives: Device: Cardiovascular ultrasound |
| Control group | No intervention | The control group received conventional drug treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-sensitivity C-reactive protein (hs-CRP) in serum
High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.
Measured: Day 11 after PCI
Interleukin-6 (IL-6) levels
high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions
Measured: Day 11 after PCI
Secondary outcomes (37)
creatine kinase isoenzymes
Serum creatine kinase isoenzyme levels in fasting were collected and measured
Measured: From enrollment to the end of treatment at 3rd month
cardiac troponin I
Serum cardiac troponin I levels in fasting were collected and measured
Measured: From enrollment to the end of treatment at 3rd month
myeloperoxidase
Serum myeloperoxidase levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
total cholesterol
Serum total cholesterol levels in fasting were collected and measured
Measured: From enrollment to the end of treatment at 3rd month
triglyceride
Serum triglyceride levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
low-density lipoprotein cholesterol
Serum low-density lipoprotein cholesterol levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
high-density lipoprotein cholesterol
Serum high-density lipoprotein cholesterol levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
apolipoprotein A
Serum apolipoprotein A levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
apolipoprotein B
Serum apolipoprotein B levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
lipoprotein (a)
Serum lipoprotein (a) levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
oxidized low-density lipoprotein
Serum-oxidized low-density lipoprotein levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
endothelial nitric oxide synthase
Serum endothelial nitric oxide synthase levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
endothelin-1
Serum endothelin-1 levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
vascular endothelial growth factor
Serum vascular endothelial growth factor levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
procalcitonin
Serum procalcitonin levels in fasting were collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Stroke Systemic Vascular Resistance Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Mean Arterial Pressure
Mean Arterial Pressure was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Stroke Volume Index
Stroke Volume Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Stroke Volume
Stroke Volume levels was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Cardiac Output
Cardiac Output was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Cardiac Index
The Cardiac Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Left Ventricular Stroke Work Index
The left Ventricular Stroke Work Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance Index
The systemic Vascular Resistance Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Ejection Phase Contraction Index
Ejection Phase Contraction Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Inotropic State Index
Inotropic State Index was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Systemic Vascular Resistance was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Vascular Resistance
Vascular Resistance was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Mean Heart Rate
Mean Heart Rate was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
left ventricular ejection fraction
left ventricular ejection fraction was collected and measured
Measured: From enrollment to the end of treatment at 3rd month
Wall thickening fraction
Wall thickening fraction was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
E/E'
E/E\' was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
6-minute walk test
A 6-minute walk test was collected and measured.
Measured: From enrollment to the end of treatment at 3rd month
Patient Health Questionnaire-9
Patient Health Questionnaire-9 was scored and collected. The Patient Health Questionnaire-9 (PHQ-9) serves as a critical instrument for the screening, diagnosis, and assessment of depression, enabling the measurement of its severity.
Measured: From enrollment to the end of treatment at 3rd month
7-item Generalized Anxiety Disorder Scale
A 7-item Generalized Anxiety Disorder Scale (GAD-7) was scored and collected. GAD-7 acts as an essential tool for evaluating generalized anxiety disorder
Measured: From enrollment to the end of treatment at 3rd month
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI)was scored and collected. the Pittsburgh Sleep Quality Index (PSQI) stands as a widely recognized assessment tool for determining sleep quality.
Measured: From enrollment to the end of treatment at 3rd month
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) was scored and collected. SAQ functions as a self-administered assessment tool designed to evaluate specific functional status and quality of life among individuals with coronary artery disease.
Measured: From enrollment to the end of treatment at 3rd month
Heart rate variability
Heart rate variability was scored and collected. Heart rate variability (HRV) refers to the fluctuation in the timing of consecutive heartbeats or the variance in heart rate. It is determined by the duration between two successive R-R intervals, representing the slight deviation between each cardiac cycle. HRV assessment was conducted using the ZSY-1 Rhythm Variability Analyzer, with the patient in a supine position, and short-term (5-minute) HRV was measured during daytime hours (8:00-16:00) while at rest.
Measured: From enrollment to the end of treatment at 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Peng, MD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640400
- Sponsor's protocol ID
- KYLL-202308-006
- Status last verified
- Sep 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data is related to participant privacy. The data that support the findings of this study are available on request from the corresponding author \[Lin Shen\].
Publications
Liang W, Liang B, Yan K, Zhang G, Zhuo J, Cai Y. Low-Intensity Pulsed Ultrasound: A Physical Stimulus with Immunomodulatory and Anti-inflammatory Potential. Ann Biomed Eng. 2024 Aug;52(8):1955-1981. doi: 10.1007/s10439-024-03523-y. Epub 2024 Apr 29.
PubMed 38683473Zhu H, He M, Wang YL, Zhang Y, Dong J, Chen BY, Li YL, Zhou LJ, Du LJ, Liu Y, Zhang WC, Ta D, Duan SZ. Low-intensity pulsed ultrasound alleviates doxorubicin-induced cardiotoxicity via inhibition of S100a8/a9-mediated cardiac recruitment of neutrophils. Bioeng Transl Med. 2023 Jul 7;8(6):e10570. doi: 10.1002/btm2.10570. eCollection 2023 Nov.
PubMed 38023700Watanabe T, Matsumoto Y, Nishimiya K, Shindo T, Amamizu H, Sugisawa J, Tsuchiya S, Sato K, Morosawa S, Ohyama K, Watanabe-Asaka T, Hayashi M, Kawai Y, Takahashi J, Yasuda S, Shimokawa H. Low-intensity pulsed ultrasound therapy suppresses coronary adventitial inflammatory changes and hyperconstricting responses after coronary stent implantation in pigs in vivo. PLoS One. 2021 Sep 13;16(9):e0257175. doi: 10.1371/journal.pone.0257175. eCollection 2021.
PubMed 34516572Signori LU, Rubin Neto LJ, Jaenisch RB, Puntel GO, Nunes GS, Paulitsch FS, Hauck M, Silva AMVD. Effects of therapeutic ultrasound on the endothelial function of patients with type 2 diabetes mellitus. Braz J Med Biol Res. 2023 Jun 26;56:e12576. doi: 10.1590/1414-431X2023e12576. eCollection 2023.
PubMed 37377306de Avila Santana L, Alves JM, Andrade TA, Kajiwara JK, Garcia SB, Gomes FG, Frade MA. Clinical and immunohistopathological aspects of venous ulcers treatment by Low-Intensity Pulsed Ultrasound (LIPUS). Ultrasonics. 2013 Apr;53(4):870-9. doi: 10.1016/j.ultras.2012.12.009. Epub 2012 Dec 23.
PubMed 23294989Shindo T, Ito K, Ogata T, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Hasebe Y, Nishimiya K, Shiroto T, Takahashi J, Okumura Y, Noguchi T, Ozaki Y, Daida H, Hagiwara N, Masuyama T, Chikamori T, Fukumoto Y, Tsujita K, Kanai H, Yasuda S, Shimokawa H. A randomized, double-blind, placebo-controlled pilot trial of low-intensity pulsed ultrasound therapy for refractory angina pectoris. PLoS One. 2023 Jun 23;18(6):e0287714. doi: 10.1371/journal.pone.0287714. eCollection 2023.
PubMed 37352324Shindo T, Ito K, Ogata T, Hatanaka K, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Aizawa K, Shiroto T, Kasukabe S, Miyata S, Taki H, Hasegawa H, Kanai H, Shimokawa H. Low-Intensity Pulsed Ultrasound Enhances Angiogenesis and Ameliorates Left Ventricular Dysfunction in a Mouse Model of Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2016 Jun;36(6):1220-9. doi: 10.1161/ATVBAHA.115.306477. Epub 2016 Apr 14.
PubMed 27079882Li J, Zhang Q, Ren C, Wu X, Zhang Y, Bai X, Lin Y, Li M, Fu J, Kopylov P, Wang S, Yu T, Wang N, Xu C, Zhang Y, Yang B. Low-Intensity Pulsed Ultrasound Prevents the Oxidative Stress Induced Endothelial-Mesenchymal Transition in Human Aortic Endothelial Cells. Cell Physiol Biochem. 2018;45(4):1350-1365. doi: 10.1159/000487561. Epub 2018 Feb 15.
PubMed 29462805Hu Y, Jia Y, Wang H, Cao Q, Yang Y, Zhou Y, Tan T, Huang X, Zhou Q. Low-intensity pulsed ultrasound promotes cell viability and inhibits apoptosis of H9C2 cardiomyocytes in 3D bioprinting scaffolds via PI3K-Akt and ERK1/2 pathways. J Biomater Appl. 2022 Sep;37(3):402-414. doi: 10.1177/08853282221102669. Epub 2022 May 15.
PubMed 35574901Sun P, Li Y, Yu W, Chen J, Wan P, Wang Z, Zhang M, Wang C, Fu S, Mang G, Choi S, Du Z, Tang C, Li S, Shi G, Tian J, Dai J, Leng X. Low-intensity pulsed ultrasound improves myocardial ischaemia-reperfusion injury via migrasome-mediated mitocytosis. Clin Transl Med. 2024 Jul;14(7):e1749. doi: 10.1002/ctm2.1749.
PubMed 38951127Weng L, Li L, Zhao K, Xu T, Mao Y, Shu H, Chen X, Chen J, Wu J, Guo X, Tu J, Zhang D, Sun W, Kong X. Non-Invasive Local Acoustic Therapy Ameliorates Diabetic Heart Fibrosis by Suppressing ACE-Mediated Oxidative Stress and Inflammation in Cardiac Fibroblasts. Cardiovasc Drugs Ther. 2022 Jun;36(3):413-424. doi: 10.1007/s10557-021-07297-6. Epub 2022 Feb 14.
PubMed 35156147Zhao K, Zhang J, Xu T, Yang C, Weng L, Wu T, Wu X, Miao J, Guo X, Tu J, Zhang D, Zhou B, Sun W, Kong X. Low-intensity pulsed ultrasound ameliorates angiotensin II-induced cardiac fibrosis by alleviating inflammation via a caveolin-1-dependent pathway. J Zhejiang Univ Sci B. 2021 Oct 15;22(10):818-838. doi: 10.1631/jzus.B2100130.
PubMed 34636186Zhao K, Weng L, Xu T, Yang C, Zhang J, Ni G, Guo X, Tu J, Zhang D, Sun W, Kong X. Low-intensity pulsed ultrasound prevents prolonged hypoxia-induced cardiac fibrosis through HIF-1alpha/DNMT3a pathway via a TRAAK-dependent manner. Clin Exp Pharmacol Physiol. 2021 Nov;48(11):1500-1514. doi: 10.1111/1440-1681.13562. Epub 2021 Aug 14.
PubMed 34343366Monma Y, Shindo T, Eguchi K, Kurosawa R, Kagaya Y, Ikumi Y, Ichijo S, Nakata T, Miyata S, Matsumoto A, Sato H, Miura M, Kanai H, Shimokawa H. Low-intensity pulsed ultrasound ameliorates cardiac diastolic dysfunction in mice: a possible novel therapy for heart failure with preserved left ventricular ejection fraction. Cardiovasc Res. 2021 Apr 23;117(5):1325-1338. doi: 10.1093/cvr/cvaa221.
PubMed 32683442Jiang X, Savchenko O, Li Y, Qi S, Yang T, Zhang W, Chen J. A Review of Low-Intensity Pulsed Ultrasound for Therapeutic Applications. IEEE Trans Biomed Eng. 2019 Oct;66(10):2704-2718. doi: 10.1109/TBME.2018.2889669. Epub 2018 Dec 25.
PubMed 30596564
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06640400
- Acronym / sponsor ID
- KYLL-202308-006
- Conditions
- Coronary Heart Disease
- Keywords
- cardiovascular ultrasound, PCI, rehabilitation, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are:
Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI.
Participants will:
Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days.
Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3.
Their symptoms were recorded, and depression and anxiety were scored.
Detailed description
Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking.
Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software.
Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Cardiovascular ultrasoundThe intervention group received cardiovascular ultrasound plus conventional drug therapy. |
| Control group | No intervention | –The control group received conventional drug treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Age of enrollment at least 18 years 2. Patients with confirmed coronary artery disease requiring elective PCI 3. TIMI flow grade 2 or above after PCI 4. No intraoperative complications of PCI such as entrapment, reflux, or perforation of coronary artery.
- 5. The skin in the anterior chest area is intact and not broken. 6. Cardiac enzymes and troponin I are within normal range before enrollment. Exclusion Criteria
- Patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction.
- Occlusion of branch vessels during PCI.
- Patients with perioperative use of hormones or immunosuppressants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular ultrasoundParticipants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart\'s long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments. | Device | Intervention group |
Primary outcome
high-sensitivity C-reactive protein (hs-CRP) in serum
Time frame: Day 11 after PCI
High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.
Interleukin-6 (IL-6) levels
Time frame: Day 11 after PCI
high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions
37 secondary outcomes
creatine kinase isoenzymes
Time frame: From enrollment to the end of treatment at 3rd month
cardiac troponin I
Time frame: From enrollment to the end of treatment at 3rd month
myeloperoxidase
Time frame: From enrollment to the end of treatment at 3rd month
total cholesterol
Time frame: From enrollment to the end of treatment at 3rd month
triglyceride
Time frame: From enrollment to the end of treatment at 3rd month
low-density lipoprotein cholesterol
Time frame: From enrollment to the end of treatment at 3rd month
high-density lipoprotein cholesterol
Time frame: From enrollment to the end of treatment at 3rd month
apolipoprotein A
Time frame: From enrollment to the end of treatment at 3rd month
apolipoprotein B
Time frame: From enrollment to the end of treatment at 3rd month
lipoprotein (a)
Time frame: From enrollment to the end of treatment at 3rd month
oxidized low-density lipoprotein
Time frame: From enrollment to the end of treatment at 3rd month
endothelial nitric oxide synthase
Time frame: From enrollment to the end of treatment at 3rd month
endothelin-1
Time frame: From enrollment to the end of treatment at 3rd month
vascular endothelial growth factor
Time frame: From enrollment to the end of treatment at 3rd month
procalcitonin
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Time frame: From enrollment to the end of treatment at 3rd month
Mean Arterial Pressure
Time frame: From enrollment to the end of treatment at 3rd month
Stroke Volume Index
Time frame: From enrollment to the end of treatment at 3rd month
Stroke Volume
Time frame: From enrollment to the end of treatment at 3rd month
Cardiac Output
Time frame: From enrollment to the end of treatment at 3rd month
Cardiac Index
Time frame: From enrollment to the end of treatment at 3rd month
Left Ventricular Stroke Work Index
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance Index
Time frame: From enrollment to the end of treatment at 3rd month
Ejection Phase Contraction Index
Time frame: From enrollment to the end of treatment at 3rd month
Inotropic State Index
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Time frame: From enrollment to the end of treatment at 3rd month
Vascular Resistance
Time frame: From enrollment to the end of treatment at 3rd month
Mean Heart Rate
Time frame: From enrollment to the end of treatment at 3rd month
left ventricular ejection fraction
Time frame: From enrollment to the end of treatment at 3rd month
Wall thickening fraction
Time frame: From enrollment to the end of treatment at 3rd month
E/E'
Time frame: From enrollment to the end of treatment at 3rd month
6-minute walk test
Time frame: From enrollment to the end of treatment at 3rd month
Patient Health Questionnaire-9
Time frame: From enrollment to the end of treatment at 3rd month
7-item Generalized Anxiety Disorder Scale
Time frame: From enrollment to the end of treatment at 3rd month
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 3rd month
Seattle Angina Questionnaire (SAQ)
Time frame: From enrollment to the end of treatment at 3rd month
Heart rate variability
Time frame: From enrollment to the end of treatment at 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 38683473Liang W, Liang B, Yan K, Zhang G, Zhuo J, Cai Y. Low-Intensity Pulsed Ultrasound: A Physical Stimulus with Immunomodulatory and Anti-inflammatory Potential. Ann Biomed Eng. 2024 Aug;52(8):1955-1981. doi: 10.1007/s10439-024-03523-y. Epub 2024 Apr 29.
- Results publication: PubMed 38023700Zhu H, He M, Wang YL, Zhang Y, Dong J, Chen BY, Li YL, Zhou LJ, Du LJ, Liu Y, Zhang WC, Ta D, Duan SZ. Low-intensity pulsed ultrasound alleviates doxorubicin-induced cardiotoxicity via inhibition of S100a8/a9-mediated cardiac recruitment of neutrophils. Bioeng Transl Med. 2023 Jul 7;8(6):e10570. doi: 10.1002/btm2.10570. eCollection 2023 Nov.
- Results publication: PubMed 34516572Watanabe T, Matsumoto Y, Nishimiya K, Shindo T, Amamizu H, Sugisawa J, Tsuchiya S, Sato K, Morosawa S, Ohyama K, Watanabe-Asaka T, Hayashi M, Kawai Y, Takahashi J, Yasuda S, Shimokawa H. Low-intensity pulsed ultrasound therapy suppresses coronary adventitial inflammatory changes and hyperconstricting responses after coronary stent implantation in pigs in vivo. PLoS One. 2021 Sep 13;16(9):e0257175. doi: 10.1371/journal.pone.0257175. eCollection 2021.
- Results publication: PubMed 37377306Signori LU, Rubin Neto LJ, Jaenisch RB, Puntel GO, Nunes GS, Paulitsch FS, Hauck M, Silva AMVD. Effects of therapeutic ultrasound on the endothelial function of patients with type 2 diabetes mellitus. Braz J Med Biol Res. 2023 Jun 26;56:e12576. doi: 10.1590/1414-431X2023e12576. eCollection 2023.
- Results publication: PubMed 23294989de Avila Santana L, Alves JM, Andrade TA, Kajiwara JK, Garcia SB, Gomes FG, Frade MA. Clinical and immunohistopathological aspects of venous ulcers treatment by Low-Intensity Pulsed Ultrasound (LIPUS). Ultrasonics. 2013 Apr;53(4):870-9. doi: 10.1016/j.ultras.2012.12.009. Epub 2012 Dec 23.
- Results publication: PubMed 37352324Shindo T, Ito K, Ogata T, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Hasebe Y, Nishimiya K, Shiroto T, Takahashi J, Okumura Y, Noguchi T, Ozaki Y, Daida H, Hagiwara N, Masuyama T, Chikamori T, Fukumoto Y, Tsujita K, Kanai H, Yasuda S, Shimokawa H. A randomized, double-blind, placebo-controlled pilot trial of low-intensity pulsed ultrasound therapy for refractory angina pectoris. PLoS One. 2023 Jun 23;18(6):e0287714. doi: 10.1371/journal.pone.0287714. eCollection 2023.
- Results publication: PubMed 27079882Shindo T, Ito K, Ogata T, Hatanaka K, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Aizawa K, Shiroto T, Kasukabe S, Miyata S, Taki H, Hasegawa H, Kanai H, Shimokawa H. Low-Intensity Pulsed Ultrasound Enhances Angiogenesis and Ameliorates Left Ventricular Dysfunction in a Mouse Model of Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2016 Jun;36(6):1220-9. doi: 10.1161/ATVBAHA.115.306477. Epub 2016 Apr 14.
- Results publication: PubMed 29462805Li J, Zhang Q, Ren C, Wu X, Zhang Y, Bai X, Lin Y, Li M, Fu J, Kopylov P, Wang S, Yu T, Wang N, Xu C, Zhang Y, Yang B. Low-Intensity Pulsed Ultrasound Prevents the Oxidative Stress Induced Endothelial-Mesenchymal Transition in Human Aortic Endothelial Cells. Cell Physiol Biochem. 2018;45(4):1350-1365. doi: 10.1159/000487561. Epub 2018 Feb 15.
- Results publication: PubMed 35574901Hu Y, Jia Y, Wang H, Cao Q, Yang Y, Zhou Y, Tan T, Huang X, Zhou Q. Low-intensity pulsed ultrasound promotes cell viability and inhibits apoptosis of H9C2 cardiomyocytes in 3D bioprinting scaffolds via PI3K-Akt and ERK1/2 pathways. J Biomater Appl. 2022 Sep;37(3):402-414. doi: 10.1177/08853282221102669. Epub 2022 May 15.
- Results publication: PubMed 38951127Sun P, Li Y, Yu W, Chen J, Wan P, Wang Z, Zhang M, Wang C, Fu S, Mang G, Choi S, Du Z, Tang C, Li S, Shi G, Tian J, Dai J, Leng X. Low-intensity pulsed ultrasound improves myocardial ischaemia-reperfusion injury via migrasome-mediated mitocytosis. Clin Transl Med. 2024 Jul;14(7):e1749. doi: 10.1002/ctm2.1749.
- Results publication: PubMed 35156147Weng L, Li L, Zhao K, Xu T, Mao Y, Shu H, Chen X, Chen J, Wu J, Guo X, Tu J, Zhang D, Sun W, Kong X. Non-Invasive Local Acoustic Therapy Ameliorates Diabetic Heart Fibrosis by Suppressing ACE-Mediated Oxidative Stress and Inflammation in Cardiac Fibroblasts. Cardiovasc Drugs Ther. 2022 Jun;36(3):413-424. doi: 10.1007/s10557-021-07297-6. Epub 2022 Feb 14.
- Results publication: PubMed 34636186Zhao K, Zhang J, Xu T, Yang C, Weng L, Wu T, Wu X, Miao J, Guo X, Tu J, Zhang D, Zhou B, Sun W, Kong X. Low-intensity pulsed ultrasound ameliorates angiotensin II-induced cardiac fibrosis by alleviating inflammation via a caveolin-1-dependent pathway. J Zhejiang Univ Sci B. 2021 Oct 15;22(10):818-838. doi: 10.1631/jzus.B2100130.
- Individual participant dataSharing planned: No. The study data is related to participant privacy. The data that support the findings of this study are available on request from the corresponding author [Lin Shen].
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Peng, MD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular ultrasound in people with Coronary Heart Disease, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, MD (18560082257, slmm321@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-sensitivity C-reactive protein (hs-CRP) in serum (time frame: Day 11 after PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640400, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.