Coronary Artery DiseaseNCT03398096
Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
A study testing Cardiac shock wave therapy in people with Coronary Artery Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac shock wave therapy
- 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
- 30 Mar 2018to 30 Sep 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were 18 to 80 years old;
- Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
- Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
- Hospitalized more than 2 times within 1 year due to the aforementioned problems;
- CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
- More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.
Who cannot join
- AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
- History of heart transplantation;
- History of metal valve replacement surgery;
- Intra-cardiac thrombus;
- Left Ventricular Ejection Fraction (LVEF) < 30 % and unstable hemodynamics;
- Arrhythmia with a rate < 40 bpm or > 120 bpm;
- Skin ulceration or infection in the treatment area;
- Severe obstructive lung disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac shock wave therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac shock wave therapyDevice
Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac shock wave therapy (CSWT) group | Experimental | The CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany. Receives: Device: Cardiac shock wave therapy |
| Control group | No intervention | No CWST treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Cardiovascular Society (CCS) grading of angina
questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance
Measured: 6 months
Seattle angina questions (SAQ)
questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality
Measured: 6 months
6-min walk test
All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy
Measured: 6 months
Nitrate consumption
All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start30 Mar 2018 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398096
- Sponsor's protocol ID
- CSWT
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.
PubMed 34368242
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT03398096
- Acronym / sponsor ID
- CSWT
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 12 Jan 2018 (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.
Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac shock wave therapy (CSWT) group | Experimental | Device: Cardiac shock wave therapyThe CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany. |
| Control group | No intervention | –No CWST treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients were 18 to 80 years old;
- Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
- Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
- Hospitalized more than 2 times within 1 year due to the aforementioned problems;
- CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
Key exclusion criteria (8 listed)
- AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
- History of heart transplantation;
- History of metal valve replacement surgery;
- Intra-cardiac thrombus;
- Left Ventricular Ejection Fraction (LVEF) < 30 % and unstable hemodynamics;
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 therapyUltrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease. | Device | Cardiac shock wave therapy (CSWT) group |
Primary outcome
Canadian Cardiovascular Society (CCS) grading of angina
Time frame: 6 months
questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance
Seattle angina questions (SAQ)
Time frame: 6 months
questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality
6-min walk test
Time frame: 6 months
All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy
Nitrate consumption
Time frame: 6 months
All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 34368242Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac shock wave therapy in people with Coronary Artery Disease, run by Shanghai 10th People's 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 6 inclusion and 8 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 12 Jan 2018. 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 Weijing Liu (18917684041, liuweijing98@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Cardiovascular Society (CCS) grading of angina (time frame: 6 months). The study lists 4 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 NCT03398096, which also lists 1 linked publication.
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 12 Jan 2018.