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

Study Overview
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Brief Summary
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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: A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR. Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.

Official Title
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Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease

Conditions
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Angina Pectoris

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Placebo.


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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angina. IMR. Statin.<br> | Drug: Rosuvastatin<br>* Rosuvastatin 20 mg once daily vs placebo for 6 months<br>|
| Placebo Comparator: Angina. IMR. Placebo.<br> | Drug: Placebo.<br>* Placebo once daily vs rosuvastatin for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |