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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582165
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Ole Geir Solberg, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE April 16, 2012
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date September 27, 2016
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
Official Title  ICMJE Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Angina Pectoris
Intervention  ICMJE
  • Drug: Rosuvastatin
    Rosuvastatin 20 mg once daily vs placebo for 6 months
  • Drug: Placebo.
    Placebo once daily vs rosuvastatin for 6 months
Study Arms  ICMJE
  • Active Comparator: Angina. IMR. Statin.
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Angina. IMR. Placebo.
    Intervention: Drug: Placebo.
Publications * Solberg OG, Stavem K, Ragnarsson A, Beitnes JO, Skårdal R, Seljeflot I, Ueland T, Aukrust P, Gullestad L, Aaberge L. Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):660-668. doi: 10.1002/ccd.28157. Epub 2019 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
66
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
60
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582165
Other Study ID Numbers  ICMJE 3tcAZ
2011-002630-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Analyses of the study will start within a few weeks or months. Publication planned in 2017
Responsible Party Ole Geir Solberg, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Aaberge, MD, PhD Oslo University Hospital Rikshospitalet, Oslo, Norway
PRS Account Oslo University Hospital
Verification Date September 2016

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