NCT00352937

Brief Summary

To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

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

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

3.8 years

First QC Date

July 14, 2006

Last Update Submit

May 14, 2014

Conditions

Coronary Arteriosclerosis

Keywords

Coronary ArteriosclerosisTomography, X-Ray ComputedTomography, Emission-Computed, Single-Photon

Outcome Measures

Primary Outcomes (1)

  • Calcium score

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients without prior CAD referred for nuclear stress testing

You may qualify if:

  • Referred for a clinical indicated stress SPECT MPI
  • Adequate IV access in both arms

You may not qualify if:

  • History of coronary angioplasty or stent placement
  • History of coronary bypass surgery
  • Angiographic history of flow-limiting CAD
  • Documented history of elevated cardiac markers
  • Documented history of injury or infarct on ECG
  • Absence of sinus rhythm
  • Current history of renal insufficiency
  • Known allergy to contrast dye
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Veterans Affairs Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Wen-Chih Wu, MD

    Providence VAMC

    PRINCIPAL INVESTIGATOR

  • Victor H Shin, MD

    Providence VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations

US(1)