Coronary Artery DiseaseNCT04694157
Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients
An observational study of Coronary Artery Disease, run by Beijing Hospital at 1 site in China.
Trial summary
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cardiac shock wave therapy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 20 Jun 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Severe CAD patients were enrolled and coronary angiography indicated complicated severe lesions. Although they were under OMT, stress myocardial perfusion imaging (MPI) showed obvious ischemia. They were not candidate for coronary revascularization.
Who may be able to join
- Multiple or diffused coronary artery stenosis via coronary angiography, and not the candidates for PCI or CABG;
- Myocardial ischemia documented by stressed MPI and echocardiography;
- Refractory angina that has not been alleviated after at least three months of optimal medication treatment (OMT);
- Left ventricular ejection fraction (LVEF) ≥ 30%.
Who cannot join
- Acute myocardial infarction within one month;
- PCI or CABG within one month;
- Heart transplant patient;
- Patients with prosthetic valves;
- Cases of atrial or ventricular thrombosis;
- Uncontrolled heart failure with LVEF <30%;
Show all 13Show fewer
- Severe arrhythmia; (viii) patients with pacemakers;
- Cases of infective endocarditis;
- Chronic obstructive pulmonary disease patients;
- Pregnant or nursing women;
- Patients with silicone breast implants;
- Chest tumor patients;
- Patients already participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Lingling Yu, +8601085138105, bjyyec@126.com
Liu, +8601085138105, bjyyec@126.com
About this study
Official title: Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients - An Observational Long-term Study
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness.The previous RCT from the investigators' team has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. The participants will be followed up at 13th week, 6th months and 12th months.
Read the detailed description
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness. In the previous clinical studies, CSWT can alleviated angina symptom, improved myocardial ischemia and increased exertional capacity. Many single arm studies proved its efficacy and safety. Our RCT has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, follow by a 3-week non-treatment interval. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. Symptom, 6MWT and questionnaires will be evaluated at baseline and 13th week, 6th months, 12th months of CSWT. Imaging outcomes will be evaluated at baseline and 13th week, 12th months of CSWT. The level of TNT, CKMB and BNP will be tested before and 1st week after initiation of CSWT.
- Conditions
- Coronary Artery Disease
- Being tested
- cardiac shock wave therapy
- Keywords
- coronary artery disease, myocardial ischemia, cardiac shock wave therapy, myocardial perfusion imaging
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac shock wave therapyDevice
Two target segments of left ventricle will be chosen for all participants. In each target segment, 9 sties will be administered with 200 shots at each site. Low-intensity SW (200 impulses/spot; energy flux 0.09 mJ/mm2), will be administered under electrocardiographic R-wave gating. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, followed by a 3-week non-treatment interval.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | The treatment group will receive cardiac shock wave therapy. The CSWT entire treatment will period last 3 months with 9 sessions. CSWT will administered in the first week, followed by a 3-week non-treatment interval. Receives: Device: cardiac shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Rest Score
Summed Rest Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 68. Higher score means worse ischemia.
Measured: Change from Baseline Summed Rest Score at 12 months.
Summed Stress Score
Summed Stress Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Measured: Change from Baseline Summed Stress Score at 12 months.
Summed Reverse Score
Summed Reverse Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Measured: Change from Baseline Summed Reverse Score at 12 months.
Regional Rest Score
Rest Score of target treatment segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Measured: Change from Baseline Regional Rest Score at 12 months.
Regional Stress Score
Stress Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Measured: Change from Baseline Regional Stress Score at 12 months.
Regional Reverse Score
Reverse Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Measured: Change from Baseline Regional Reverse Score at 12 months.
Secondary outcomes (6)
CCS score
Canadian Cardiovascular Society score. The score is from 1 to 4 score. Higher score means worse ischemia.
Measured: Change from Baseline CCS score at 12 months.
NYHA classification
Now York Heart Association classification. The score is from 1 to 4. Higher score means worse heart function.
Measured: Change from Baseline NYHA classification at 12 months.
Seattle Angina Questionnaire
Seattle Angina Questionnaire has five domain: physical limitation, angina stability, angina frequency, treatment satisfaction and quality of life. Each domain are 0-100 scale.
Measured: Change from Baseline NYHA classification at 12 months.
QOL: SF-36 Questionnaire
SF-36 Questionnaire include vitality, physical functioning, body pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Each items are 0-100 scale.
Measured: Change from Baseline SF-36 score at 12 months.
Six minutes walk test
Six minutes walk test proceed according to ATS guideline. The total distance will be recored.
Measured: Change from Baseline 6MWT at 12 months.
Left ventricular ejection fraction
Left ventricular ejection fraction on echocardiography
Measured: Change from Baseline status at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start20 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qing He, MD, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694157
- Sponsor's protocol ID
- 121-2016004-2
- Status last verified
- Jan 2022
- First submitted
- 17 Apr 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sorry for that because of policy constraint.
Publications
Zhang Y, Shen T, Liu B, Dai D, Cai J, Zhao C, Du L, Jia N, He Q. Cardiac Shock Wave Therapy Attenuates Cardiomyocyte Apoptosis after Acute Myocardial Infarction in Rats. Cell Physiol Biochem. 2018;49(5):1734-1746. doi: 10.1159/000493616. Epub 2018 Sep 24.
PubMed 30248666Qiu Q, Shen T, Wang Q, Yu X, Jia N, He Q. Cardiac shock wave therapy protects cardiomyocytes from hypoxia-induced injury by modulating miR-210. Mol Med Rep. 2020 Feb;21(2):631-640. doi: 10.3892/mmr.2019.10892. Epub 2019 Dec 18.
PubMed 31974607Liu B, Zhang Y, Jia N, Lan M, Du L, Zhao D, He Q. Study of the Safety of Extracorporeal Cardiac Shock Wave Therapy: Observation of the Ultrastructures in Myocardial Cells by Transmission Electron Microscopy. J Cardiovasc Pharmacol Ther. 2018 Jan;23(1):79-88. doi: 10.1177/1074248417725877. Epub 2017 Sep 1.
PubMed 28862043Du L, Shen T, Liu B, Zhang Y, Zhao C, Jia N, Wang Q, He Q. Shock Wave Therapy Promotes Cardiomyocyte Autophagy and Survival during Hypoxia. Cell Physiol Biochem. 2017;42(2):673-684. doi: 10.1159/000477885. Epub 2017 Jun 15.
PubMed 28618416Yu W, Shen T, Liu B, Wang S, Li J, Dai D, Cai J, He Q. Cardiac shock wave therapy attenuates H9c2 myoblast apoptosis by activating the AKT signal pathway. Cell Physiol Biochem. 2014;33(5):1293-303. doi: 10.1159/000358697. Epub 2014 Apr 28.
PubMed 24802592
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients - An Observational Long-term Study
- ClinicalTrials.gov ID
- NCT04694157
- Acronym / sponsor ID
- 121-2016004-2
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, myocardial ischemia, cardiac shock wave therapy, myocardial perfusion imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 5 Jan 2021 (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.
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness.The previous RCT from the investigators' team has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. The participants will be followed up at 13th week, 6th months and 12th months.
Detailed description
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness. In the previous clinical studies, CSWT can alleviated angina symptom, improved myocardial ischemia and increased exertional capacity. Many single arm studies proved its efficacy and safety. Our RCT has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, follow by a 3-week non-treatment interval. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. Symptom, 6MWT and questionnaires will be evaluated at baseline and 13th week, 6th months, 12th months of CSWT. Imaging outcomes will be evaluated at baseline and 13th week, 12th months of CSWT. The level of TNT, CKMB and BNP will be tested before and 1st week after initiation of CSWT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Device: cardiac shock wave therapyThe treatment group will receive cardiac shock wave therapy. The CSWT entire treatment will period last 3 months with 9 sessions. CSWT will administered in the first week, followed by a 3-week non-treatment interval. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Severe CAD patients were enrolled and coronary angiography indicated complicated severe lesions. Although they were under OMT, stress myocardial perfusion imaging (MPI) showed obvious ischemia. They were not candidate for coronary revascularization.
Key inclusion criteria (4 listed)
- Multiple or diffused coronary artery stenosis via coronary angiography, and not the candidates for PCI or CABG;
- Myocardial ischemia documented by stressed MPI and echocardiography;
- Refractory angina that has not been alleviated after at least three months of optimal medication treatment (OMT);
- Left ventricular ejection fraction (LVEF) ≥ 30%.
Key exclusion criteria (13 listed)
- Acute myocardial infarction within one month;
- PCI or CABG within one month;
- Heart transplant patient;
- Patients with prosthetic valves;
- Cases of atrial or ventricular thrombosis;
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 |
|---|---|---|
| cardiac shock wave therapyTwo target segments of left ventricle will be chosen for all participants. In each target segment, 9 sties will be administered with 200 shots at each site. Low-intensity SW (200 impulses/spot; energy flux 0.09 mJ/mm2), will be administered under electrocardiographic R-wave gating. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, followed by a 3-week non-treatment interval. | Device | Treatment group |
Primary outcome
Summed Rest Score
Time frame: Change from Baseline Summed Rest Score at 12 months.
Summed Rest Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 68. Higher score means worse ischemia.
Summed Stress Score
Time frame: Change from Baseline Summed Stress Score at 12 months.
Summed Stress Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Summed Reverse Score
Time frame: Change from Baseline Summed Reverse Score at 12 months.
Summed Reverse Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Regional Rest Score
Time frame: Change from Baseline Regional Rest Score at 12 months.
Rest Score of target treatment segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Regional Stress Score
Time frame: Change from Baseline Regional Stress Score at 12 months.
Stress Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Regional Reverse Score
Time frame: Change from Baseline Regional Reverse Score at 12 months.
Reverse Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
6 secondary outcomes
CCS score
Time frame: Change from Baseline CCS score at 12 months.
NYHA classification
Time frame: Change from Baseline NYHA classification at 12 months.
Seattle Angina Questionnaire
Time frame: Change from Baseline NYHA classification at 12 months.
QOL: SF-36 Questionnaire
Time frame: Change from Baseline SF-36 score at 12 months.
Six minutes walk test
Time frame: Change from Baseline 6MWT at 12 months.
Left ventricular ejection fraction
Time frame: Change from Baseline status at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Results publication: PubMed 30248666Zhang Y, Shen T, Liu B, Dai D, Cai J, Zhao C, Du L, Jia N, He Q. Cardiac Shock Wave Therapy Attenuates Cardiomyocyte Apoptosis after Acute Myocardial Infarction in Rats. Cell Physiol Biochem. 2018;49(5):1734-1746. doi: 10.1159/000493616. Epub 2018 Sep 24.
- Results publication: PubMed 31974607Qiu Q, Shen T, Wang Q, Yu X, Jia N, He Q. Cardiac shock wave therapy protects cardiomyocytes from hypoxia-induced injury by modulating miR-210. Mol Med Rep. 2020 Feb;21(2):631-640. doi: 10.3892/mmr.2019.10892. Epub 2019 Dec 18.
- Results publication: PubMed 28862043Liu B, Zhang Y, Jia N, Lan M, Du L, Zhao D, He Q. Study of the Safety of Extracorporeal Cardiac Shock Wave Therapy: Observation of the Ultrastructures in Myocardial Cells by Transmission Electron Microscopy. J Cardiovasc Pharmacol Ther. 2018 Jan;23(1):79-88. doi: 10.1177/1074248417725877. Epub 2017 Sep 1.
- Results publication: PubMed 28618416Du L, Shen T, Liu B, Zhang Y, Zhao C, Jia N, Wang Q, He Q. Shock Wave Therapy Promotes Cardiomyocyte Autophagy and Survival during Hypoxia. Cell Physiol Biochem. 2017;42(2):673-684. doi: 10.1159/000477885. Epub 2017 Jun 15.
- Results publication: PubMed 24802592Yu W, Shen T, Liu B, Wang S, Li J, Dai D, Cai J, He Q. Cardiac shock wave therapy attenuates H9c2 myoblast apoptosis by activating the AKT signal pathway. Cell Physiol Biochem. 2014;33(5):1293-303. doi: 10.1159/000358697. Epub 2014 Apr 28.
- Individual participant dataSharing planned: No. Sorry for that because of policy constraint.
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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.
Qing He, MD principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Beijing Hospital 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 4 inclusion and 13 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 6 Jan 2022. 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 Lingling Yu, MD (+8601085138105, bjyyec@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed Rest Score (time frame: Change from Baseline Summed Rest Score at 12 months.). The study lists 6 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 NCT04694157, which also lists 5 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 6 Jan 2022.