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:
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease|
- Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)). [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Angina pectoris classification (CCS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Angina. IMR. Statin.||
Rosuvastatin 20 mg once daily vs placebo for 6 months
|Placebo Comparator: Angina. IMR. Placebo.||
Placebo once daily vs rosuvastatin for 6 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582165
|Contact: Ole G Solberg, MD||+47 firstname.lastname@example.org|
|Oslo University Hospital, Dep of Cardiology, Rikshospitalet||Recruiting|
|Oslo, Norway, 0380|
|Principal Investigator: Ole Geir Solberg, MD|
|Principal Investigator:||Lars Aaberge, MD, PhD||Oslo University Hospital Rikshospitalet, Oslo, Norway|