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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348569
• Other study ID #: GE-189-002
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: January 31, 2007

Study information

• Verified date: April 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 31, 2007
• Est. primary completion date: January 31, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 64 Channel VCT

Locations

Country	Name	City	State
United States	Robert Centofanti, MS	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States,