Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease Patients

NCT04694157 | Unknown

• 1 other identifier: 121-2016004-2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; myocardial ischemia; cardiac shock wave therapy; myocardial perfusion imaging

Outcome Measures

Primary Outcomes (6)

• Summed Rest Score

  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

  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

  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

  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

  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

  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 Outcomes (6)

• CCS score

  Change from Baseline CCS score at 12 months.

• NYHA classification

  Change from Baseline NYHA classification at 12 months.

• Seattle Angina Questionnaire

  Change from Baseline NYHA classification at 12 months.

• QOL: SF-36 Questionnaire

  Change from Baseline SF-36 score at 12 months.

• Six minutes walk test

  Change from Baseline 6MWT at 12 months.

Other Outcomes (2)

• Cardiac enzyme

  Change from Baseline status at 13th week after treatment.

• Brain Natrium Peptide

  Change from Baseline status at 13th week after treatment.

Study Arms (1)

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.

Device: cardiac shock wave therapy

Interventions

cardiac shock wave therapy DEVICE

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.

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 30248666 RESULT

• 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.

  PMID: 31974607 RESULT

• 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.

  PMID: 28862043 RESULT

• 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.

  PMID: 28618416 RESULT

• 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.

  PMID: 24802592 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum to test cardiac enzyme

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Qing He, MD

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingling Yu, MD

CONTACT

+8601085138105; bjyyec@126.com

Wei Liu

CONTACT

+8601085138105; bjyyec@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: January 5, 2021
• Study Start: January 20, 2021
• Primary Completion: January 1, 2023
• Study Completion: June 20, 2023
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)