A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

April 26, 2019 updated by: GE Healthcare

An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
    • Acute myocardial infarction
    • Cardiac shock
    • Acute pulmonary edema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 64 Channel VCT
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Study Director: Robert Centofanti, MS, GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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