Clinical trial NCT00705458: Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain
Official title: A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Unstable Angina
Acute Coronary Syndrome
Keywords: stress myocardial perfusion imaging
coronary computed tomography angiography
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Albert Einstein College of Medicine
First posted: 2008-06-26
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.


Eligibility criteria: Inclusion Criteria:

* patient admitted for chest pain or pressure
* patient at intermediate short term risk of MI or death (AHA/ACC guidelines)

Exclusion Criteria:

* prior diagnosis of coronary artery disease
* evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines)
* contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade
* pregnancy
* presence of an implanted pacemaker or defibrillator
* stress myocardial perfusion imaging, coronary CTA or coronary catheterization within the last 6 months

Primary outcomes:
measure: Coronary catheterization that does not lead to re-vascularization
timeFrame: 1 year
Secondary outcomes:
measure: Length of Hospital Stay (time to discharge)
timeFrame: usually from hours to a few days (average about one day)
measure: Non-fatal myocardial infarction
timeFrame: 1 year
measure: Death (all cause)
timeFrame: 1 year
measure: Post-test renal dysfunction
timeFrame: usually within a few days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Moses Division, Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Linda B Haramati, MD, MS
role: STUDY_DIRECTOR
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Jeffrey M Levsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levsky JM, Travin MI, Spevack DM, Menegus MA, Huang PW, Goldberg Y, Clark ET, Banoth P, Freeman KD, Tobin JN, Haramati LB. Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain. J Cardiovasc Comput Tomogr. 2009 Jul-Aug;3(4):264-71. doi: 10.1016/j.jcct.2009.05.006. Epub 2009 May 21.
citation: Levsky JM, Spevack DM, Travin MI, Menegus MA, Huang PW, Clark ET, Kim CW, Hirschhorn E, Freeman KD, Tobin JN, Haramati LB. Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Patients With Chest Pain Admitted to Telemetry: A Randomized Trial. Ann Intern Med. 2015 Aug 4;163(3):174-83. doi: 10.7326/M14-2948.