Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    60
  • sponsor
    Beijing Hospital
Updated on 22 March 2022
angiography
stenosis
ischemia
coronary artery stenosis
bypass graft
nitroglycerin

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.

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.

Details
Condition Coronary Artery Disease
Treatment Cardiac shock wave therapy
Clinical Study IdentifierNCT04694157
SponsorBeijing Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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