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

NCT01582165 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-09-27

No results posted yet for this study

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.

Conditions

  • Angina Pectoris

Interventions

DRUG

Rosuvastatin

Rosuvastatin 20 mg once daily vs placebo for 6 months

DRUG

Placebo.

Placebo once daily vs rosuvastatin for 6 months

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Lars Aaberge, MD, PhD · Oslo University Hospital Rikshospitalet, Oslo, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582165 on ClinicalTrials.gov