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

NCT01582165 | Completed Phase 4

• 2 other identifiers: 3tcAZ2011-002630-39
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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. 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. 2.Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Angina pectoris classification (CCS).

  6 months

Study Arms (2)

Angina. IMR. Statin.

ACTIVE COMPARATOR

Drug: Rosuvastatin

Angina. IMR. Placebo.

PLACEBO COMPARATOR

Drug: Placebo.

Interventions

Rosuvastatin DRUG

Rosuvastatin 20 mg once daily vs placebo for 6 months

Angina. IMR. Statin.

Placebo. DRUG

Placebo once daily vs rosuvastatin for 6 months

Angina. IMR. Placebo.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Dep of Cardiology, Rikshospitalet

Oslo, Oslo County, 0380, Norway

Location

Related Publications (1)

• 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.

  PMID: 30790446 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lars Aaberge, MD, PhD

  Oslo University Hospital Rikshospitalet, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 20, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

NO (1)