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Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients

NCT04694157 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-01-06

No results posted yet for this study

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). 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.

Conditions

Interventions

DEVICE

cardiac shock wave therapy

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.

Sponsors & Collaborators

  • Beijing Hospital

    lead OTHER_GOV

Principal Investigators

  • Qing He, MD · Beijing Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-01-01
Completion
2023-06-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04694157 on ClinicalTrials.gov