Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients

January 5, 2022 updated by: Beijing Hospital

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lingling Yu, MD
  • Phone Number: +8601085138105
  • Email: bjyyec@126.com

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qing He, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • 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%;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Summed Rest Score at 12 months.
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.
Change from Baseline Summed Stress Score at 12 months.
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.
Change from Baseline Summed Reverse Score at 12 months.
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.
Change from Baseline Regional Rest Score at 12 months.
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.
Change from Baseline Regional Stress Score at 12 months.
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.
Change from Baseline Regional Reverse Score at 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CCS score
Time Frame: Change from Baseline CCS score at 12 months.
Canadian Cardiovascular Society score. The score is from 1 to 4 score. Higher score means worse ischemia.
Change from Baseline CCS score at 12 months.
NYHA classification
Time Frame: Change from Baseline NYHA classification at 12 months.
Now York Heart Association classification. The score is from 1 to 4. Higher score means worse heart function.
Change from Baseline NYHA classification at 12 months.
Seattle Angina Questionnaire
Time Frame: Change from Baseline NYHA classification at 12 months.
Seattle Angina Questionnaire has five domain: physical limitation, angina stability, angina frequency, treatment satisfaction and quality of life. Each domain are 0-100 scale.
Change from Baseline NYHA classification at 12 months.
QOL: SF-36 Questionnaire
Time Frame: Change from Baseline SF-36 score at 12 months.
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.
Change from Baseline SF-36 score at 12 months.
Six minutes walk test
Time Frame: Change from Baseline 6MWT at 12 months.
Six minutes walk test proceed according to ATS guideline. The total distance will be recored.
Change from Baseline 6MWT at 12 months.
Left ventricular ejection fraction
Time Frame: Change from Baseline status at 12 months
Left ventricular ejection fraction on echocardiography
Change from Baseline status at 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac enzyme
Time Frame: Change from Baseline status at 13th week after treatment.
Serum Troponin T, CKMB
Change from Baseline status at 13th week after treatment.
Brain Natrium Peptide
Time Frame: Change from Baseline status at 13th week after treatment.
Serum brain Natrium Peptide
Change from Baseline status at 13th week after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Qing He, MD, Beijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

June 20, 2023

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

January 1, 2021

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sorry for that because of policy constraint.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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