Comprehensive Treatment of Angina in Women With Microvascular Dysfunction (CORA)
Angina Pectoris, Coronary Microvascular Disease
About this trial
This is an interventional prevention trial for Angina Pectoris
Eligibility Criteria
Inclusion Criteria:
Patients will be recruited and included from the ongoing iPower study.(the acronym iPower stands for: improving diagnosis and treatment of women with angina pectoris and microvascular disease)
- Female gender
- 40-75 years of age
- Referred to a cardiac centre for assessment with coronary angiography due to chest pain or other signs of ischemia leaving out ST-segment elevation myocardial Infarction (STEMI) or NSTEMI patients (elevated enzymes, electrocardiographic (ECG) changes/no ECG changes)
No significant stenotic lesions at the following coronary angiography defined as > 50% stenosis of epicardial vessels. Patients are included within 1 year after coronary angiography.
- Angina with a symptom burden of symptoms > monthly
- Impaired coronary microvascular function, defined as a Transthoracic Doppler Echocardiography measured CFVR < 2.5 with a good quality (quality index > 3)
- BMI > 26 or BMI >= 25 combined with a waist hip ratio of >=0.8
- Informed consent
Exclusion Criteria:
- Previously verified myocardial infarction, verified in medical records: ST-elevation myocardial infarction, elevated coronary markers or Non ST-elevation myocardial infarction
- Previous percutaneous coronary intervention or coronary artery bypass graft.
- Left ventricular ejection fraction (LVEF) < 45% assessed by echocardiography within 6 months before inclusion
- Any allergies to the content of the low energy diet (gluten/nuts), allergy to dipyridamole, adenosine, or theophyllamine
- Significant valvular heart disease
- Congenital heart disease
- Severe asthma
- Severe chronic obstructive pulmonary disease (COPD): forced expiratory volume in 1st second (FEV1) < 50% of predicted (age, height, ethnicity)
- Severe comorbidity with limited life-expectancy < 1 year
- Chest pain with a strongly suspected non-ischemic etiology (e.g. pericarditis, pneumonia)
- Pregnancy
- Active cancer
- Renal (eGFR < 30) or severe hepatic comorbidity
- Chronic alcohol abuse
- Atrial flutter or fibrillation
- Atrioventricular block > 1st degree
- Diabetes Mellitus type II patients in treatment with Sulphonylureas
- Participation in other trials if relevant for the present study
- Language- or other barrier to giving informed consent
- Physical or mental disabilities contraindicating or hampering diet or exercise training
- Travel distance to research hospital requiring more than 3 hours of travel, making it difficult for the patient to participate
Withdrawal criteria
- Sudden unexpected serious adverse reaction or sustained side effects
- Poor compliance will lead to withdrawal from the study at the mentioned time points: Low energy diet: No weight loss within the first 3 weeks of the intervention period. Medication: < 80% of the prescribed medicine taken within the first 3 weeks. Training: < 50% attendance to training sessions/home training within the first 5 weeks.
Sites / Locations
- Bispebjerg Hospital, Dept. of Cardiology Y builing 67, 1.floor, Bispebjerg Bakke 23
- Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Weight loss, training, medication
Control
The intervention program consists of a comprehensive 24-week treatment period of: 1) Body weight loss without significant loss of muscle mass, through low energy diet combined with 2) Exercise training based on interval training and resistance exercise and 3) Optimal medical treatment for hypertension and hypercholesterolemia (with statin and ACE-inhibition). Further, participants in this allocation group receive nutrition counselling. The diet products are sponsored by Cambridge Weight Plan. No persons with interest in Cambridge Weight Plan will take part in the intervention phase, analyzing phase, data processing, or publication of data in this study.
The control group receives 24 weeks of usual care according to guidelines of Danish Cardiology Society. Treatment of angina pectoris in absence of coronary artery disease is normally provided by the patient's general practitioner and does not comprise intensive lifestyle intervention or medical treatment. If control group participants in this study need medical therapy for hypertension or hypercholesterolemia, this will be effectuated by the researcher, MD. Then, control participants will be monitored with blood pressure and LDL blood samples and receive medicine adjustments according to National Prevention Guidelines during the full study period.