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OpenTrials
Completed

NCT Number: NCT01582165

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

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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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital, Dep of Cardiology, Rikshospitalet

Oslo, 0380, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 20 mg once daily vs placebo for 6 months

Placebo.

Drug

Placebo once daily vs rosuvastatin for 6 months

Primary outcomes

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

    Time frame: 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 outcomes

  1. Angina pectoris classification (CCS).

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2012
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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