Effect of ACE-Inhibition on Microvascular Function in Women With Assessed Microvascular Dysfunction

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to explore effects of long term treatment with ACE-inhibitor on the small vessel function assessed by coronary flow reserve (CFR) by transthoracic echocardiography and flow mediated dilation in normotensive patients with small vessel disease (CFR<2.2) and Angina Pectoris but no obstructive coronary artery disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Ramipril

Criteria

Inclusion Criteria:

• Patients from an established cohort of patients with non obstructive coronary artery disease

• Microvascular dysfunction defined as a transthoracic echocardiography measured coronary flow reserve (CFR) < 2.2

• A good quality (quality index > 3) examination

• A blood pressure ≤ 150 at last visit in iPower

• Patients who are not in treatment for documented hypertension

Exclusion Criteria:

• Current treatment with ACE-inhibitors or Angiotensin II-antagonists

• Atrial fibrillation

• Pace-maker

• Allergy towards Ace-inhibitor, Ramipril ® or tool-medicine: Dipyridamole/adenosine, Nitro-glycerine or rescue medicine: Theophylline

• Baseline CFR >2.5 when entering ACIM-study.

• No episodes of chest pain within 6 months before inclusion

• Coronary angiography with significant stenotic lesions (>/=50%)

• Other cause of chest discomfort deemed highly likely

• Left ventricular ejection fraction below 45% assessed by echocardiography at baseline measurement

• Significant valvular heart disease (Definition: Verified in medical records after echocardiography. If the echocardiographer in this study suspects valvular heart disease, the patient is referred for expert evaluation and excluded from the study until valvular disease has been excluded. All definitions are taken from the guidelines of the Danish Society of Cardiology (DCS).

• Haemodynamic significant Aortic Stenosis: Valve area < 1 cm2 or <0.6 cm2/m2 body surface area.

• Severe aorta Regurgitation (AR): Vena contracta > 6 mm, Moderate/severe left ventricle (LV) volume load, ERO > 0.3 cm².

• Mitral Stenosis (MS): Valve area < 2.5 cm2.

• Severe Mitral Regurgitation (MR): effective regurgitant orifice > 0.4 cm², Moderate/severe LV-load, Vena contracta > 6 mm.

• Congenital heart disease or cardiomyopathy verified in medical records

• Significant co-morbidity with < 1 year expected survival: decision made by the person responsible for inclusion based on the patient interview and/or medical records.

• Severe chronic obstructive pulmonary disease with forced expiratory volume in 1 second (FEV1)<50% of predicted

• Severe asthma defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (long acting β2 agonist (LABA), leukotriene modifier, theophylline or systemic corticosteroids) to prevent it from becoming uncontrolled or which remains uncontrolled despite this therapy."

• Previous verified myocardial infarction (Definition: verified in medical records, ST segment elevation myocardial infarction (STEMI) (ST segment elevation, elevated enzymes) or non-ST-segment elevation myocardial infarction (NSTEMI) (elevated enzymes, ECG changes/no ECG changes).

• Previous revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting)

• Elevated cardiac biomarkers: Troponin > 50 ng/l (high sensitive) or > 0.03 μg/l (4. generation), creatinin kinase myoglobin (CKMB) > 4.0 μg/l (women).

• ECG with verified ST-segment elevation

• Language- or other barrier to giving informed consent (for example mental ability to understand project)

• Travel distance: a distance to research hospital requiring more than 3 hours of travel

• Patient unwilling to participate (Low burden of symptoms, other illnesses, "Lack of energy", transport problems, anxiety because of the examination, other).

• No signed informed consent.

• Other (Pregnancy, significant psychiatric disorder)

• glomerular filtration rate < 50 mL/min/1,73 m2