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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01582165

Enrollment

Registered

2012-04-20

Start date

2012-06-30

Completion date

2016-06-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris

Brief summary

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.

Interventions

DRUGRosuvastatin

Rosuvastatin 20 mg once daily vs placebo for 6 months

DRUGPlacebo.

Placebo once daily vs rosuvastatin for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 70 Years

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).	6 months	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.

Secondary

Measure	Time frame	Description
Angina pectoris classification (CCS).	6 months	Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026