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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763464
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Postmenopausal Women Stable Angina Pectoris Procedure: stress-echocardiography Procedure: stress-MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Coronary Artery Disease in Postmenopausal Women. Comparison of Myocardial Szintigraphy With Sress-Echocardiography and Stress-MRI.
Study Start Date : October 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

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


Primary Outcome Measures :
  1. comparision of different ischemia diagnostic methods [ Time Frame: before routine coronary angiography ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763464


Locations
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Germany
Department of Cardiology, RWTH Aachen University Hospital
Aachen, Germany, 52057
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Michael Becker, MD Medical Faculty of the RWTH Aachen University
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Responsible Party: Michael Becker, MD, Medical Clinic I, Medical Faculty of the RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00763464    
Other Study ID Numbers: CAD female 2006-MB
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011
Keywords provided by RWTH Aachen University:
Coronary Artery Disease
ischemia diagnostic
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations