Coronary Artery Disease (CAD) in Postmenopausal Women | NCT00763464

Studies
Coronary Artery Disease (CAD) in Postmenopausal Women

NCT00763464

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Jul 7, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Postmenopausal Women
Stable Angina Pectoris

Interventions

stress-echocardiography
stress-MRI

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Apr 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Sep 29, 2008

First Posted Date

Oct 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stress-echocardiography	Procedure	stress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue)
stress-MRI	Procedure	stress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparision of different ischemia diagnostic methods		before routine coronary angiography

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Becker, MD	Medical Faculty of the RWTH Aachen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, RWTH Aachen University Hospital		Aachen		52057	Germany

Condition Browse Module

MeSH Terms

ID	Term
D060050	Angina, Stable
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided