Status:
COMPLETED
A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain
Lead Sponsor:
GE Healthcare
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 atypic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2007
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00348569
Start Date
May 1 2006
End Date
January 31 2007
Last Update
April 29 2019
Active Locations (1)
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1
Robert Centofanti, MS
Princeton, New Jersey, United States, 08540