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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

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:

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.

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Detailed Description

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Conditions

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Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Angina. IMR. Statin.

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 20 mg once daily vs placebo for 6 months

Angina. IMR. Placebo.

Group Type PLACEBO_COMPARATOR

Placebo.

Intervention Type DRUG

Placebo once daily vs rosuvastatin for 6 months

Interventions

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Rosuvastatin

Rosuvastatin 20 mg once daily vs placebo for 6 months

Intervention Type DRUG

Placebo.

Placebo once daily vs rosuvastatin for 6 months

Intervention Type DRUG

Eligibility Criteria

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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 -

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No