NCT00284466

Brief Summary

The purpose of the study is to compare the pictures of heart arteries obtained by MSCT scanner to the pictures obtained during heart catheterization. Our specific question is whether the MSCT scanner is accurate enough to replace heart catheterization in some situations for the evaluation of coronary heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 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

January 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

January 27, 2006

Last Update Submit

August 28, 2012

Conditions

Keywords

coronary artery diseasecardiac catheterizationCT coronary angiographycoronary angiography

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is the ability of CTA to detect coronary disease of greater than 50% diameter stenosis (sensitivity, specificity, positive and negative predictive value) analyzed on a subject basis.

    assess at time of CTA

Secondary Outcomes (3)

  • Assess CTA performance on both a vessel and coronary segment basis

    assessed at time of CTA

  • Estimate the impact of coronary calcium score on ability to assess for coronary disease

    assessed at time of CTA

  • Evaluate impact of scan quality of CTA performance measures

    assessed at time of CTA

Interventions

MS-CT Coronary Angiography done

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects \>18 years old with stable clinical symptoms who are scheduled for outpatient cardiac catheterization.
  • Able to provide written informed consent in accordance with the IRB.

You may not qualify if:

  • Symptoms of unstable angina/acute coronary syndrome
  • Known allergy or adverse reaction to CT radiocontrast and/or iodine.
  • Known absolute contraindication to Metoprolol.
  • Significant kidney disease including creatinine \> 1.5 mg/dL or GFR \< 60 ml/min.
  • Inability to breath-hold for up to 30 seconds.
  • Women who are Pregnant or Nursing
  • Atrial Fibrillation or any other arrhythmia that makes attaining a regular slow rhythm unlikely.
  • History of previous stent placement or coronary bypass surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jon G Keevil, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations