Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

Coronary Artery Disease Clinical Trial

Official title:

Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03398096
• Other study ID #: CSWT
• Status: Not yet recruiting
• Phase: N/A
• First received: December 14, 2017
• Last updated: January 7, 2018
• Start date: March 30, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2018
• Source: Shanghai 10th People's Hospital
• Contact: Weijing Liu
• Phone: 18917684041
• Email: liuweijing98[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients were 18 to 80 years old;

• Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;

• Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);

• Hospitalized more than 2 times within 1 year due to the aforementioned problems;

• CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;

• More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.

Exclusion Criteria:

• AMI?PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;

• History of heart transplantation;

• History of metal valve replacement surgery;

• Intra-cardiac thrombus;

• Left Ventricular Ejection Fraction (LVEF) < 30 % and unstable hemodynamics;

• Arrhythmia with a rate < 40 bpm or > 120 bpm;

• Skin ulceration or infection in the treatment area;

• Severe obstructive lung disease.

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cardiac shock wave therapy
Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Cardiovascular Society (CCS) grading of angina	questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance	6 months
Primary	Seattle angina questions (SAQ)	questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality	6 months
Primary	6-min walk test	All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy	6 months
Primary	Nitrate consumption	All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy	6 months