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:
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
  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:

  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.

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:

  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 -
  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 April 17, 2014