Retrospective

Cheuk Man Yu

Rm.12A28, 12/F, main building, PWH

2632 1752

cmyu@cuhk.edu.hk / poonsps@yahoo.com.hk

Nil

Cheuk Man Yu / Sheung Poon

Rm.12A28, 12/F, main building, PWH

2632 1752

cmyu@cuhk.edu.hk / poonsps@yahoo.com.hk

Nil

明德醫院和香港中文大學共同合作，對缺血性心肌病進行體外震波治療的研究

Yes

2008-04-07

Procedure

Shock Wave therapy the patients with Ischemic Myocardium

2 years

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 will undergo baseline exercise testing, echocardiography, magnetic resonance imaging, and questionnaire assessment of symptoms. 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 of the study. Three blood tests will be taken during the first 12 hours after shock wave to monitor cardiac muscle enzyme and growth factor enzymes. 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 would be performed at 6 and 12 months FU. Patients randomized to non treatment arm will undergo MRI, exercise tests, questionnaires and echocardiography but will not attend for shock wave therapy.

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 female
patient who is of reproductive potential agrees to remain abstinent or use (or have
their 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 of
contraceptives.
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

1. Pregnancy or lactation.
2. Any other condition which in the opinion of the investigator may either put the patient at risk or influence the result of the study (eg. severe respiratory disease, severe valvular disease, cardiogenic shock, active myocarditis / endocarditis, hemodynamic instability, malignancy, non-compliance, risk of lost to follow up, conditions leading to life expectancy of less than 24 months).
3. Participation in other clinical trial within 6 months of enrollment.
4. Recent myocardial infarction within 6 months.
5. Unable to consent to or perform components of the study

18 years of age

85 year of age

Both Male and Female

Randomized

Active

Open label

Parallel

No

Yes

Nil