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Coronary Artery Disease (CAD) in Postmenopausal Women (FEMCAD)

Primary Purpose

Postmenopausal Women, Stable Angina Pectoris

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

stress-echocardiography

stress-MRI

About this trial

This is an interventional diagnostic trial for Postmenopausal Women focused on measuring Coronary Artery Disease, ischemia diagnostic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Cardiology, RWTH Aachen University Hospital

Outcomes

Primary Outcome Measures

comparision of different ischemia diagnostic methods

Secondary Outcome Measures

Full Information

NCT ID

NCT00763464

First Posted

September 29, 2008

Last Updated

July 6, 2011

Sponsor

RWTH Aachen University

1. Study Identification

Unique Protocol Identification Number

NCT00763464

Brief Title

Coronary Artery Disease (CAD) in Postmenopausal Women

Acronym

FEMCAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

RWTH Aachen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Women, Stable Angina Pectoris

Keywords

Coronary Artery Disease, ischemia diagnostic

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

stress-echocardiography

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

stress-MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

comparision of different ischemia diagnostic methods

Time Frame

before routine coronary angiography

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Becker, MD

Organizational Affiliation

Medical Faculty of the RWTH Aachen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Cardiology, RWTH Aachen University Hospital

City

Aachen

ZIP/Postal Code

52057

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Coronary Artery Disease (CAD) in Postmenopausal Women

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