NCT00921440

Brief Summary

The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

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

August 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

Enrollment Period

11 months

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

Keywords

coronary arterystenosis

Eligibility Criteria

Age51 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people with suspected or known coronary artery disease (CAD)

You may qualify if:

  • Clinically known or presumed CAD
  • Age \> 50 years
  • Hospitalization for invasive coronary angiography
  • Sinus rhythm
  • Written informed consent by the patient to participate in the study after comprehensive presentation of the facts

You may not qualify if:

  • Age \<= 50 years
  • Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism)
  • Arrhythmias
  • Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction
  • Pregnancy
  • Implanted pacemaker
  • Unwillingness of patient to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseConstriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Krug, Prof. Dr.

    Dept. of Radiology, University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 16, 2009

Record last verified: 2009-06