Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease (CSWT)

Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial

Coronary heart disease (CHD) is a public health care challenge. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT. There are only three cities in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

Study Overview

• Status: Completed
• Conditions: Cardiac Ischemia
• Intervention / Treatment: Device: Cardiac shock wave therapy; Other: Sham cardiac shock wave (Control group)

Detailed Description

Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of people died in China every year. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients with severe cardiac ischemia lost the chance to get those treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. German and Japan are the countries earliest used CSWT. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT by objective examination. New small vessels generation on ischemia area was found on mice and pig model. There are only three cities in China run the program of CSWT, that are Kunming, Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;
2. Myocardial ischemia and/or cardiac dysfunction by objective exams;
3. Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;
4. LVEF is above 30%;
5. Signed informed consent

Exclusion Criteria:

1. Acute myocardial infarction;
2. Within one month after PCI or CABG;
3. Heart transplant patient;
4. Mechanic valve implantation patient;
5. Uncontrolled heart failure with LVEF less than 30%;
6. Severe arrhythmia;
7. Pacemaker implantation patient;
8. Infective endocarditis;
9. Severe chronic obstructive pulmonary disease patient;
10. Pregnant or nursing patient;
11. Silicone breast forms patient;
12. Chest tumor patient;
13. Participant in other clinical trials at the same time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSWT group; Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month.	Device: Cardiac shock wave therapy; Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks.; Other Names: CSWT group
Sham Comparator: Sham CSWT group; Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion.	Other: Sham cardiac shock wave (Control group); Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.; Other Names: Sham CSWT group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial perfusion score	Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.	1st week of fourth month from beginning of CSWT
Ischemia area percentage	Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.	1st week of fourth month from beginning of CSWT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac wall motion amplitude	Cardiac wall motion amplitude rate will be calculated by single-photon computer tomography.	1st week of fourth month from beginning of CSWT
Left ventricular thickness rate	Left ventricular thickness rate will be calculated by single-photon computer tomography.	1st week of fourth month from beginning of CSWT
Cardiac enzyme	Troponin T and troponin I will be tested at last time shock wave therapy of the first week.	First week after CSWT
Angina score-SAQ	SAQ angina score will be finished after three month of CSWT.	1st week of fourth month from beginning of CSWT
Quality of life (SF-36)	SF-36 questionnaire will be used for QOL.	1st week of fourth month from beginning of CSWT
Six-minute of walk test	6MWT will be used for exertional capacity.	1st week of fourth month from beginning of CSWT

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Principal Investigator: Qing He, Beijing Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cardiac ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: 121-2016004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No