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A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348569
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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 with typical or atypical chest pain suspected of coronary artery disease (CAD).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: 64 Channel VCT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective, Multicenter Study of GE LightSpeed Volume Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain Patients Suspected of Coronary Artery Disease
Study Start Date : May 2006
Actual Primary Completion Date : January 31, 2007
Actual Study Completion Date : January 31, 2007

Resource links provided by the National Library of Medicine


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 2 to 21 days later by catheter coronary angiography (CATH).
Device: 64 Channel VCT




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has typical or atypical chest pain suspected of CAD and is referred for an elective coronary angiography.
  • The subject must be scheduled to undergo a CATH procedure between 48 hours and 3 weeks post CCTA procedure.
  • The subject must not undergo any cardiac interventional treatment between the 2 procedures.
  • The subject must have sinus rhythm with stable heart rate of ≤65 beats per minute (bpm) or if heart rate was >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.

Exclusion Criteria:

  • The subject had an established diagnosis of CAD by a) previous CATH, b) prior myocardial infarction confirmed by ECG, or c) prior revascularization (balloon angioplasty, stent placement, or CABG).
  • The subject had a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
  • The subject had impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
  • The subject had atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
  • The subject had a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100mm Hg.
  • The subject had an artificial heart valve(s).
  • The subject has had prior pacemaker or internal defibrillator lead implantation.
  • The subject's resting heart rate was >65 bpm and beta-blocker therapy was contraindicated.
  • The subject had a contraindication to verapamil when beta-blocker therapy could not be administered. The subject had a contraindication to nitroglycerin.
  • The subject had evidence of ongoing or active clinical instability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348569


Locations
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United States, New Jersey
Robert Centofanti, MS
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Robert Centofanti, MS GE Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00348569    
Other Study ID Numbers: GE-189-002
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Keywords provided by GE Healthcare:
CT
Coronary
Cardiac
Angiography
X-ray
CAD
Chest pain
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations