refractory angina with incomplete revascularization
Conditions
Interventions
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Had a history of coronary artery disease with refractory angina [Canadian Cardiovascular Society (CCS) class II to III] despite optimal medical therapy for at least one month; Optimal medical therapy is defined as guideline-recommended treatment including secondary prevention and at least two antianginal drugs: one is nitrates, another is beta-blocker or calcium channel blocker, except for medication contraindications; 3. With incomplete revascularization (ICR). ICR is defined as the presence of >=1 lesion with visually estimated >=50% diameter stenosis in any coronary artery (including branch vessels) of >=2.0 mm in diameter, whether in the target vessel or in a nontarget vessel. In the case of a participant post-CABG, ICR is defined as the presence of >=1 lesion with visually estimated >=50% diameter stenosis in a nonbypassed epicardial vessel >=2.0 mm in diameter, or >=1 visually estimated >=50% diameter stenosis in a bypass graft supplying an otherwise nonrevascularized myocardial territory. 4. The ejection fraction >=30%; 5. Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome within 1 month or planned coronary revascularization during the study period; 2. Episode of transient ischemia attack, ischemic or hemorrhagic stroke within 2 months; 3. Presence of neuromuscular, orthopedic or other non-cardiac condition such as severe peripheral artery disease, severe pulmonary hypertension and uncontrolled chronic obstructive pulmonary disease or asthma that prevents the patient from exercise testing on a cycle ergometer; 4. Patients with the following resting electrocardiographic abnormalities that might influence the interpretation of the termination of CPET: -Pre-excitation (Wolff-Parkinson-White) syndrome; -Electronically paced ventricular rhythm; -1 mm or more of resting ST depression -Complete left bundle-branch block or any interventricular conduction defect with a QRS duration greater than 120 ms 5. Uncontrolled symptomatic heart failure; 6. Moderate to severe symptomatic aortic stenosis; 7. Hypertrophic cardiomyopathy; 8. Acute myocarditis or pericarditis; 9. Active endocarditis; 10. Acute pulmonary embolism; 11. Suspected or known acute aortic dissection; 12. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening) 13. Severe anemia (Hemoglobin < 60 g/L); 14. Active psychosis requiring anticonvulsant treatment; 15. Pregnant or lactating women. 16. Participation in other clinical studies within 30 days before the first visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in total exercise time from baseline to week 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of VO2 at anaerobic threshold (ml/min/kg) from baseline to week 6;The changes of PETO2 at peak exercise (mmHg) from baseline to week 6;The changes of the proportion of patients experiencing an improvement of >=1 CCS angina classes from baseline to week 6;The changes of VE/VCO2 slope from baseline to week 6;The changes of O2 pulse at peak exercise (mL/beat) from baseline to week 6;The changes of Peak VO2 (ml/min/kg) from baseline to week 6;The changes of PETCO2 at peak exercise (mmHg) from baseline to week 6;The changes of the proportion of patients experiencing an improvement of >=2 CCS angina classes from baseline to week 6;The changes of ?VO2/?work-rate (ml/min/W) from baseline to week 6;The changes of angina frequency from baseline to week 6;The changes of the Seattle Angina Questionnaires scores (subdivided into 5 dimensions including physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception) from baseline to week 6;The changes of Peak work rate (W) from baseline to week 6;The changes of plasma C-reactive protein, homocysteine and NT-proBNP from baseline to week 6;The changes of Peak METs from baseline to week 6;The changes of VO2 at anaerobic threshold (ml/min) from baseline to week 6;The changes of Peak VO2 (ml/min) from baseline to week 6;The changes of frequency of nitroglycerine use from baseline to week 6; | — |
Countries
China
Contacts
Public ContactYugang Dong
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed