Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
This study is currently recruiting participants.
Verified March 2013 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01582165
First received: April 16, 2012
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Angina Pectoris |
Drug: Rosuvastatin Drug: Placebo. |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 66 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Angina. IMR. Statin. |
Drug: Rosuvastatin
Rosuvastatin 20 mg once daily vs placebo for 6 months
|
| Placebo Comparator: Angina. IMR. Placebo. |
Drug: Placebo.
Placebo once daily vs rosuvastatin for 6 months
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582165
Contacts
| Contact: Ole G Solberg, MD | +47 23070000 | ole.geir.solberg@ous-hf.no |
Locations
| Norway | |
| Oslo University Hospital, Dep of Cardiology, Rikshospitalet | Recruiting |
| Oslo, Norway, 0380 | |
| Principal Investigator: Ole Geir Solberg, MD | |
Sponsors and Collaborators
Oslo University Hospital
Investigators
| Principal Investigator: | Lars Aaberge, MD, PhD | Oslo University Hospital Rikshospitalet, Oslo, Norway |
More Information
No publications provided
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01582165 History of Changes |
| Other Study ID Numbers: | 3tcAZ, 2011-002630-39 |
| Study First Received: | April 16, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Additional relevant MeSH terms:
|
Angina Pectoris Chest Pain Coronary Artery Disease Coronary Stenosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Pain Signs and Symptoms Coronary Disease Arteriosclerosis |
Arterial Occlusive Diseases Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013