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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00763464
Other study ID # CAD female 2006-MB
Secondary ID
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


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
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