Investigation of small vessel disease in women with chest pain and normal coronary arteries

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Investigation of otherwise healthy women with chest pain without significant stenoses in their epicardial coronary arteries.

• Registration Number: EUCTR2011-002630-39-NO
• Lead Sponsor: Oslo University Hospital Rikshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-08
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1.Female gender
2.Age 30 - 60 years
3.Chest pain suggestive of symptomatic coronary artery disease
4.A coronary angiogram with no or minimal coronary artery disease
5.FFR value over 0,80

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Male gender
2.Age under 30 years or over 60
3.Coronary artery stenosis = 33 % in any epicardial vessel
4.FFR value = 0,80
5.Short life expectancy
6.Uncontrolled endocrinological disease
7.Arterial hypertension
8.Structural heart disease
9.Significant mental disorder, including dementia
10.Inability to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance.<br> <br><br>;Secondary Objective: 1. To determine whether high-dose statin treatment will modify the index of microvascular resistance in women with chest pain without significant coronary disease.<br><br>2. To determine the relationship between IMR and <br>•Inflammation<br>•Endothelial function<br>•Large vessel compliance <br><br>3. To investigate the effect of a statin on<br>•Inflammatory variables<br>•Quality of life<br>•Chest pain;Primary end point(s): The primary end point is change in index of microvascular resistance. ;Timepoint(s) of evaluation of this end point: 6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Angina functional class. Quality of life. Tonometry. Laboratory parameters of inflammation;Timepoint(s) of evaluation of this end point: 3 and 6 months