Clinical trial NCT00348569: A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CT
Coronary
Cardiac
Angiography
X-ray
CAD
Chest pain
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Robert Centofanti, MS
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Robert Centofanti, MS
role: STUDY_DIRECTOR
References:
citation: Min JK, Edwardes M, Lin FY, Labounty T, Weinsaft JW, Choi JH, Delago A, Shaw LJ, Berman DS, Budoff MJ. Relationship of coronary artery plaque composition to coronary artery stenosis severity: results from the prospective multicenter ACCURACY trial. Atherosclerosis. 2011 Dec;219(2):573-8. doi: 10.1016/j.atherosclerosis.2011.05.032. Epub 2011 May 31.
citation: Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.