Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
Primary Purpose
Angina Pectoris
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Rosuvastatin
Placebo.
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris
Eligibility 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 -
Sites / Locations
- Oslo University Hospital, Dep of Cardiology, Rikshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Angina. IMR. Statin.
Angina. IMR. Placebo.
Arm Description
Outcomes
Primary Outcome Measures
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
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).
Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.
Full Information
NCT ID
NCT01582165
First Posted
April 16, 2012
Last Updated
September 26, 2016
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01582165
Brief Title
Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
Official Title
Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Angina. IMR. Statin.
Arm Type
Active Comparator
Arm Title
Angina. IMR. Placebo.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin 20 mg once daily vs placebo for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo.
Intervention Description
Placebo once daily vs rosuvastatin for 6 months
Primary Outcome Measure Information:
Title
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Angina pectoris classification (CCS).
Description
Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Aaberge, MD, PhD
Organizational Affiliation
Oslo University Hospital Rikshospitalet, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Dep of Cardiology, Rikshospitalet
City
Oslo
ZIP/Postal Code
0380
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Analyses of the study will start within a few weeks or months. Publication planned in 2017
Citations:
PubMed Identifier
30790446
Citation
Solberg OG, Stavem K, Ragnarsson A, Beitnes JO, Skardal 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.
Results Reference
derived
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Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
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