Ischemic Cardiomyopathy
Conditions
Interventions
Two groups:Shock Wave therapy for 2 years
0:60 stable chronic angina patients with either coronary artery disease that is not amenable for revascularization or triple vessel coronary artery disease awaiting coronary artery bypass grafting wil
0:After randomization, they will then undergo ultrasound shock wave therapy for 20 minutes, three times a week on either the first, fifth, and ninth week of the study or the 18th, 23rd, and 27th week
0:MRI heart, Exercise testing, and echocardiography would be performed at 6 months and coronary artery bypass grafting would be performed at 6 months. Follow up questionnaire and clinical assessment w
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patient is male or female between 18 and 85 years of age on day of signing informed consent; 2. Contraception for female patients who are of reproductive potential: a femalepatient who is of reproductive potential agrees to remain abstinent or use (or havetheir partner use) 2 acceptable methods of birth control for the duration of the study.An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Note: Female patients who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use ofcontraceptives; 3. Patients with coronary angiography demonstrating coronary anatomy not amenable to revascularization or suitable for routine elective coronary artery bypass grafting with impaired LVEF < 40% and with substantial viable reversible myocardial ischemia in at least one vascular territory on MRI.
Exclusion criteria
Exclusion criteria: 1. Patient is male or female between 18 and 85 years of age on day of signing informed consent; 2. Contraception for female patients who are of reproductive potential: a femalepatient who is of reproductive potential agrees to remain abstinent or use (or havetheir partner use) 2 acceptable methods of birth control for the duration of the study.An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Note: Female patients who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use ofcontraceptives; 3. Patients with coronary angiography demonstrating coronary anatomy not amenable to revascularization or suitable for routine elective coronary artery bypass grafting with impaired LVEF < 40% and with substantial viable reversible myocardial ischemia in at least one vascular territory on MRI.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Improved CCS angina grade.;Improved 6 minute walk.;Improved SF-36.; | — |
Primary
| Measure | Time frame |
|---|---|
| Improved Exercise duration on standard Bruce Protocol Exercise test;Improved angina frequency.; | — |
Countries
China
Contacts
Public ContactCheuk Man Yu / Sheung Poon
Outcome results
None listed