Postmenopausal WomenFEMCADNCT00763464
Coronary Artery Disease (CAD) in Postmenopausal Women
A study testing stress-echocardiography and stress-MRI in people with Postmenopausal Women and Stable Angina Pectoris, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Postmenopausal Women, Stable Angina Pectoris
- What is being tested?
- stress-echocardiography and stress-MRI
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy
Who cannot join
- CABG
- Pacemaker or other metal implants
- Chronic bronchitis
- Asthma bronchiale
- Arterial Hypotension
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, RWTH Aachen University Hospital
Aachen, 52057
About this study
Official title: Coronary Artery Disease in Postmenopausal Women. Comparison of Myocardial Szintigraphy With Sress-Echocardiography and Stress-MRI.
Aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women.
Read the 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.
- Conditions
- Postmenopausal Women, Stable Angina Pectoris
- Being tested
- stress-echocardiography, stress-MRI
- Keywords
- Coronary Artery Disease, ischemia diagnostic
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress-echocardiographyProcedure or surgery
stress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue)
stress-MRIProcedure or surgery
stress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist)
What is being measured
The primary outcome is the main question the study is designed to answer.
comparision of different ischemia diagnostic methods
Measured: before routine coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Becker, MD, Principal investigator, Medical Faculty of the RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763464
- Sponsor's protocol ID
- CAD female 2006-MB
- Acronym
- FEMCAD
- Status last verified
- Jul 2011
- First submitted
- 29 Sep 2008
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease in Postmenopausal Women. Comparison of Myocardial Szintigraphy With Sress-Echocardiography and Stress-MRI.
- ClinicalTrials.gov ID
- NCT00763464
- Acronym / sponsor ID
- FEMCAD / CAD female 2006-MB
- Conditions
- Postmenopausal Women, Stable Angina Pectoris
- Keywords
- Coronary Artery Disease, ischemia diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy
Key exclusion criteria (5 listed)
- CABG
- Pacemaker or other metal implants
- Chronic bronchitis
- Asthma bronchiale
- Arterial Hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress-echocardiographystress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue) | Procedure or surgery | – |
| stress-MRIstress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist) | Procedure or surgery | – |
Primary outcome
comparision of different ischemia diagnostic methods
Time frame: before routine coronary angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Becker, MD principal investigator
Medical Faculty of the RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress-echocardiography and stress-MRI in people with Postmenopausal Women and Stable Angina Pectoris, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparision of different ischemia diagnostic methods (time frame: before routine coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.