Coronary Artery DiseasePhase 3NCT01578876
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
A Phase 3 study testing cardiac shock wave therapy(CSWT) in people with Coronary Artery Disease, run by Kunming Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort. Read more about this study
- Who is it for?
- Ages 35 to 81 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cardiac shock wave therapy(CSWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Jan 2012
- Phase
- Phase 3
- 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 35 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary angiography or multi-slice spiral ct coronary angiography 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.
- Canadian Cardiovascular Society angina grading higher than grade II, and New York Heart Association functional classification of I-III.
- More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007.
Who cannot join
- Acute myocardial infarction or coronary artery bypass graft within the 4 weeks prior to the study.
- History of heart transplantation.
- History of metal valve replacement surgery.
- Intracardiac thrombus.
- Left ventricular ejection fraction < 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.
About this study
Official title: To Prove up the Effect of CSWT in Vivo and to Evaluate the Feasibility and Efficiency of CSWT for Treatment of CAD and to Establish the Inclusion and Exclusion Criteria and Summarize the Methodological Outlines of CSWT in China.
The purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.
Read the detailed description
This study was approved by the Institutional Review Board and Ethics Committee of 1st Hospital of Kunming Medical University, and all study subjects signed informed consent for participation in the study and all treatments performed. Subjects were patients who were hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009.
Patients were eligible to be included in the study if they met any of the following criteria: 1) Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis. 2) Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft). 3) Hospitalized more than 2 times within 1 year due to the aforementioned problems. 4) CCS angina grading higher than grade II, and NYHA functional classification of I-III. 5) More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007
- Conditions
- Coronary Artery Disease
- Being tested
- cardiac shock wave therapy(CSWT)
- Keywords
- coronary artery disease, angina pectoris, myocardial ischemia, cardiac shock wave therapy
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac shock wave therapy(CSWT)Device
Also called SW
CSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given.
| Study group | Role | What they receive |
|---|---|---|
| CSWT for 3 month | Experimental | A group Receives: Device: cardiac shock wave therapy(CSWT) |
| CSWT for 1 month | Experimental | B group Receives: Device: cardiac shock wave therapy(CSWT) |
| Control group | No intervention | C group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
Outcome measure included clinical assessment and morphological assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startDec 2008
- Primary completionMay 2011
- Study completionJan 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Tao, Kunming Medical University
- Investigators
- Guo Tao, MD, Study director, Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578876
- Sponsor's protocol ID
- CSWT IN CHINA
- Status last verified
- Apr 2012
- First submitted
- 19 Feb 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nirala S, Wang Y, Peng YZ, Yang P, Guo T. Cardiac shock wave therapy shows better outcomes in the coronary artery disease patients in a long term. Eur Rev Med Pharmacol Sci. 2016;20(2):330-8.
PubMed 26875905
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Prove up the Effect of CSWT in Vivo and to Evaluate the Feasibility and Efficiency of CSWT for Treatment of CAD and to Establish the Inclusion and Exclusion Criteria and Summarize the Methodological Outlines of CSWT in China.
- ClinicalTrials.gov ID
- NCT01578876
- Acronym / sponsor ID
- CSWT IN CHINA
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, angina pectoris, myocardial ischemia, cardiac shock wave therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Apr 2012 (estimated)
- 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 purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.
Detailed description
This study was approved by the Institutional Review Board and Ethics Committee of 1st Hospital of Kunming Medical University, and all study subjects signed informed consent for participation in the study and all treatments performed. Subjects were patients who were hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009.
Patients were eligible to be included in the study if they met any of the following criteria: 1) Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis. 2) Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft). 3) Hospitalized more than 2 times within 1 year due to the aforementioned problems. 4) CCS angina grading higher than grade II, and NYHA functional classification of I-III. 5) More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSWT for 3 month | Experimental | Device: cardiac shock wave therapy(CSWT)A group |
| CSWT for 1 month | Experimental | Device: cardiac shock wave therapy(CSWT)B group |
| Control group | No intervention | –C group |
Who may qualify
- Ages
- 35 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- coronary angiography or multi-slice spiral ct coronary angiography 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.
- Canadian Cardiovascular Society angina grading higher than grade II, and New York Heart Association functional classification of I-III.
- More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007.
Key exclusion criteria (8 listed)
- Acute myocardial infarction or coronary artery bypass graft within the 4 weeks prior to the study.
- History of heart transplantation.
- History of metal valve replacement surgery.
- Intracardiac thrombus.
- Left ventricular ejection fraction < 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 therapy(CSWT)Also: SWCSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given. | Device | CSWT for 1 month, CSWT for 3 month |
Primary outcome
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
Time frame: 3 years
Outcome measure included clinical assessment and morphological assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- Derived from this study: PubMed 26875905Nirala S, Wang Y, Peng YZ, Yang P, Guo T. Cardiac shock wave therapy shows better outcomes in the coronary artery disease patients in a long term. Eur Rev Med Pharmacol Sci. 2016;20(2):330-8.
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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.
Guo Tao, MD study director
Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cardiac shock wave therapy(CSWT) in people with Coronary Artery Disease, run by Kunming Medical 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 5 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: finished, as of the sponsor's last update on 19 Apr 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease (time frame: 3 years). 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 NCT01578876, 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 19 Apr 2012.