Clinical trial NCT04694157: Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients
Official title: Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients - An Observational Long-term Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
myocardial ischemia
cardiac shock wave therapy
myocardial perfusion imaging
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Summed Rest Score
timeFrame: Change from Baseline Summed Rest Score at 12 months.
measure: Summed Stress Score
timeFrame: Change from Baseline Summed Stress Score at 12 months.
measure: Summed Reverse Score
timeFrame: Change from Baseline Summed Reverse Score at 12 months.
measure: Regional Rest Score
timeFrame: Change from Baseline Regional Rest Score at 12 months.
measure: Regional Stress Score
timeFrame: Change from Baseline Regional Stress Score at 12 months.
measure: Regional Reverse Score
timeFrame: Change from Baseline Regional Reverse Score at 12 months.
Secondary outcomes:
measure: CCS score
timeFrame: Change from Baseline CCS score at 12 months.
measure: NYHA classification
timeFrame: Change from Baseline NYHA classification at 12 months.
measure: Seattle Angina Questionnaire
timeFrame: Change from Baseline NYHA classification at 12 months.
measure: QOL: SF-36 Questionnaire
timeFrame: Change from Baseline SF-36 score at 12 months.
measure: Six minutes walk test
timeFrame: Change from Baseline 6MWT at 12 months.
measure: Left ventricular ejection fraction
timeFrame: Change from Baseline status at 12 months
Other outcomes:
measure: Cardiac enzyme
timeFrame: Change from Baseline status at 13th week after treatment.
measure: Brain Natrium Peptide
timeFrame: Change from Baseline status at 13th week after treatment.
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Qing He, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Shen T, Liu B, Dai D, Cai J, Zhao C, Du L, Jia N, He Q. Cardiac Shock Wave Therapy Attenuates Cardiomyocyte Apoptosis after Acute Myocardial Infarction in Rats. Cell Physiol Biochem. 2018;49(5):1734-1746. doi: 10.1159/000493616. Epub 2018 Sep 24.
citation: Qiu Q, Shen T, Wang Q, Yu X, Jia N, He Q. Cardiac shock wave therapy protects cardiomyocytes from hypoxia-induced injury by modulating miR-210. Mol Med Rep. 2020 Feb;21(2):631-640. doi: 10.3892/mmr.2019.10892. Epub 2019 Dec 18.
citation: Liu B, Zhang Y, Jia N, Lan M, Du L, Zhao D, He Q. Study of the Safety of Extracorporeal Cardiac Shock Wave Therapy: Observation of the Ultrastructures in Myocardial Cells by Transmission Electron Microscopy. J Cardiovasc Pharmacol Ther. 2018 Jan;23(1):79-88. doi: 10.1177/1074248417725877. Epub 2017 Sep 1.
citation: Du L, Shen T, Liu B, Zhang Y, Zhao C, Jia N, Wang Q, He Q. Shock Wave Therapy Promotes Cardiomyocyte Autophagy and Survival during Hypoxia. Cell Physiol Biochem. 2017;42(2):673-684. doi: 10.1159/000477885. Epub 2017 Jun 15.
citation: Yu W, Shen T, Liu B, Wang S, Li J, Dai D, Cai J, He Q. Cardiac shock wave therapy attenuates H9c2 myoblast apoptosis by activating the AKT signal pathway. Cell Physiol Biochem. 2014;33(5):1293-303. doi: 10.1159/000358697. Epub 2014 Apr 28.