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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
64 Channel VCT
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

64 Channel VCT

Arm Description

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).

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 6, 2006
Last Updated
April 26, 2019
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00350506
Brief Title
A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
Official Title
An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision (due to low subject enrollment)
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
64 Channel VCT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
64 Channel VCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Centofanti, MS
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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