Coronary Artery Disease (CAD) in Postmenopausal Women

Stable Angina Pectoris Clinical Trial

— FEMCAD  

Official title:

Coronary Artery Disease in Postmenopausal Women. Comparison of Myocardial Szintigraphy With Sress-Echocardiography and Stress-MRI.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763464
• Other study ID #: CAD female 2006-MB
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: July 6, 2011
• Start date: October 2006
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women.

Description:

In order to investigate which ischemia diagnostic presents which sensitivity and specificity for postmenopausal women, 100 consecutive patients presenting to our abmulance with stable angina pectoris and indication for myocardial szintigraphy will be enrolled in this study. An addidional stress-echocardiography and stress-MRI will be performed in this patients before they will reiceve their again routine coronay angiography.

The different methods for ischemia diagnostic will be compared in order to determine the most valid method for this specific population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy

Exclusion Criteria:

• CABG

• Pacemaker or other metal implants

• Chronic bronchitis

• Asthma bronchiale

• Arterial Hypotension

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Postmenopausal Women
• Stable Angina Pectoris

Intervention

Procedure:
• stress-echocardiography
stress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue)
• stress-MRI
stress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist)

Locations

Country	Name	City	State
Germany	Department of Cardiology, RWTH Aachen University Hospital	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparision of different ischemia diagnostic methods		before routine coronary angiography	Yes