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

NCT00348569 | Completed

• 1 other identifier: GE-189-002
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

CT; Coronary; Cardiac; Angiography; X-ray; CAD; Chest pain

Study Arms (1)

64 Channel VCT

EXPERIMENTAL

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

Interventions

64 Channel VCT DEVICE

64 Channel VCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Robert Centofanti, MS

Princeton, New Jersey, 08540, United States

Location

Related Publications (2)

• 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.

  PMID: 21696739 DERIVED

• 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.

  PMID: 19007693 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Centofanti, MS

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: May 1, 2006
• Primary Completion: January 31, 2007
• Study Completion: January 31, 2007
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

US (1)