Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance

Oslo University Hospital66 enrolled

Overview

Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary microcirculation. The index of microvascular resistance (IMR) is a method for indirectly investigating microvascular function in the cardiac catheterization laboratory. 66 female patients, age 30-70 years, with chest pain and "normal" or near normal coronary angiograms will be included. After coronary physiologic evaluation, patients will be randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for altogether 6 months. The investigators hypothesize that: 1. A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR. 2. Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Angina Pectoris

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female gender 2. Age 30 - 70 years 3. Chest pain suggestive of symptomatic coronary artery disease 4. A coronary angiogram with no or minimal coronary artery disease 5. Fractional flow reserve value over 0,80 Exclusion Criteria: 1. Male gender 2. Age under 30 years or over 70 3. Coronary artery stenosis ≥ 33 % in any epicardial vessel 4. Fractional flow reserve value ≤ 0,80 5. Pregnant or nursing women 6. Women of childbearing potential not using contraception 7. Short life expectancy 8. Uncontrolled endocrinological disease 9. Arterial hypertension 10. Structural heart disease 11. Significant mental disorder, including dementia 12. Inability to comply with the protocol -

Outcomes

Primary Outcomes

Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).

During a left heart catheterization IMR and CFR are measured at baseline and at 6 months. Patients are randomized to rosuvastatin vs placebo. The objectives are to determine whether women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance and to determine whether high-dose statin treatment will modify microvascular perfusion indices in these patients.

Time frame: 6 months

Secondary Outcomes

Angina pectoris classification (CCS).

Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.