NCT00763464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

4.5 years

First QC Date

September 29, 2008

Last Update Submit

July 6, 2011

Conditions

Postmenopausal WomenStable Angina Pectoris

Keywords

Coronary Artery Diseaseischemia diagnostic

Outcome Measures

Primary Outcomes (1)

  • comparision of different ischemia diagnostic methods

    before routine coronary angiography

Interventions

stress-echocardiographyPROCEDURE

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

stress-MRIPROCEDURE

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

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy

You may not qualify if:

  • CABG
  • Pacemaker or other metal implants
  • Chronic bronchitis
  • Asthma bronchiale
  • Arterial Hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, RWTH Aachen University Hospital

Aachen, 52057, Germany

Location

MeSH Terms

Conditions

Angina, StableCoronary Artery Disease

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Michael Becker, MD

    Medical Faculty of the RWTH Aachen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

DE(1)