refractory angina patients unsuitable for revascularization
Conditions
Interventions
intensive treatment group:compound danshen dripping pills 20 pills three times daily orally
standard treatment group:compound danshen dripping pills 10 pills and placebo 10 pills, three times daily orally
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, male or female; (2) Coronary angiography or CTA confirmed at least one coronary artery with stenosis = 50%; (3) Refractory symptoms of angina pectoris despite optimal medical therapy for at least 1 month with Canadian Cardiovascular Society (CCS) grade II~IV. The optimal medical therapy includes at least 2 kinds of anti-angina drugs, one for nitrates, another for beta blockers calcium antagonists; (4) Considered unsuitable for revascularization (CABG or PCI)by cardiovascular team (including 2 PCI doctors and 2 cardiothoracic surgeons). (5) The left ventricular ejection fraction is more than 30%;
Exclusion criteria
Exclusion criteria: (1) acute coronary syndrome within 1 months, or coronary revascularization within 6 months, or planned coronary revascularization during the experiment; (2) an episode of transient ischemia attack occurred within 2 months; (3) severe joint diseases, peripheral vascular disease, pulmonary hypertension, chronic obstructive pulmonary disease and other comorbidities that might affect the results of the cardiacpulmonary exercise test; (4) Abnormalities in electrocardiogram in the rest including preexcitation syndromeventricular pacing rhythmST segment depressed more than 2mm in the rest, left bundle branch block or any intraventricular conduction block and QRS duration more than 120ms; (5) Congenital heart defects of decompensated congestive heart failure, severe valvular disease, hypertrophic cardiomyopathy, severe uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), severe anemia, suspected or known artery dissection, acute myocarditis or pericarditis, active endocarditis, thrombophlebitis, or pulmonary embolism; (6) History of bleeding tendency, cerebral hemorrhage, or epilepsy requiring anticonvulsant treatment; (7) pregnant or lactation; (8) drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in total exercise time from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| subgroup analysis: the change of the left ventricular global strains including left ventricular longitudinal strain, overall circumferential strain, overall area strain and overall radial strain from baseline;changes in the frequency of angina pectoris episodes per week;; changes in the amounts of nitroglycerin used per week for acute angina pectoris episodes;changes in quality of life assessed weekly by Seattle Angina Questionnaire;changes in exercise tolerance and cardiac function index including VO2 max, kg oxygen uptake in kilograms, anaerobic threshold, metabolic equivalent, maximal oxygen pulse, maximum heart rate reserve, respiratory quotient and gas exchange rate etc.;changes in ventilation function indexes including respiratory reserve, maximal exercise ventilation, maximum tidal volume, maximal respiratory rate and ratio of tidal volume to deep inspiratory volume etc;changes in the gas exchange indexes including arterial oxygen pressure, alveolar arterial oxygen pressure, arterial carbon dioxide partial pressure, end tidal carbon dioxide partial pressure, arterial partial pressure of end tidal carbon dioxide, oxygen, carbon dioxide equivalent and equivalent die cavity etc.;changes in the level of C reactive protein (CRP), homocysteine, and NT-proBNP.; | — |
Countries
China
Contacts
Public ContactYugang Dong
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed