Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients

Beijing Hospital

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: cardiac shock wave therapy

Study type: Observational

Funder types: Other

Identifiers

NCT04694157

121-2016004-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Treatment group

Description:

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.

Treatment:

Device: cardiac shock wave therapy