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

April 16, 2012
March 11, 2013
June 2012
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01582165 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Angina Pectoris
  • Drug: Rosuvastatin
    Rosuvastatin 20 mg once daily vs placebo for 6 months
  • Drug: Placebo.
    Placebo once daily vs rosuvastatin for 6 months
  • Active Comparator: Angina. IMR. Statin.
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Angina. IMR. Placebo.
    Intervention: Drug: Placebo.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
August 2014
February 2014   (final data collection date for primary outcome measure)

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 -
Female
30 Years to 70 Years
No
Contact: Ole G Solberg, MD +47 23070000 ole.geir.solberg@ous-hf.no
Norway
 
NCT01582165
3tcAZ, 2011-002630-39
No
Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Lars Aaberge, MD, PhD Oslo University Hospital Rikshospitalet, Oslo, Norway
Oslo University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP