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

Angina Pectoris Clinical Trial

Official title:

Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582165
• Other study ID #: 3tcAZ
• Secondary ID: 2011-002630-39
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2012
• Last updated: September 26, 2016
• Start date: June 2012
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Chest Pain

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 20 mg once daily vs placebo for 6 months
• Placebo.
Placebo once daily vs rosuvastatin for 6 months

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Dep of Cardiology, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months	No