NCT00350506

Brief Summary

To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

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, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

July 6, 2006

Last Update Submit

April 26, 2019

Conditions

Coronary Artery Disease

Study Arms (1)

64 Channel VCT

EXPERIMENTAL

All subjects underwent Coronary Computed Tomographic Angiography (CCTA) after receiving an intravenous (IV) administration of Visipaque (320 mgI/mL), to be followed by catheter coronary angiography (CATH).

Device: 64 Channel VCT

Interventions

64 Channel VCTDEVICE
64 Channel VCT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective diagnostic catheterization OR
  • Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.
  • Age ≥18 years but ≤75 years.

You may not qualify if:

  • Prior coronary stent implantation
  • Prior coronary artery bypass grafting or other heart surgery
  • Prior pacemaker or internal defibrillator lead implantation
  • Prior artificial heart valve
  • Biochemical renal insufficiency (CrSerum \> 1.6) or on dialysis
  • Resting HR \> 100 at the time of enrollment
  • Contraindication to β-blockade or calcium channel blocker
  • NYHA-IV
  • High-grade atrioventricular (AV) block
  • Systolic blood pressure \<90 mm Hg
  • Severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease
  • Atrial fibrillation
  • Inability to provide informed consent
  • Evidence of ongoing or active clinical instability
  • Acute chest pain (sudden onset)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robert Centofanti, MS

    GE Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

US(1)