Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain

Coronary Artery Disease Clinical Trial

— PROSPECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705458
• Other study ID #: MMC-07-07-197
• Status: Completed
• Phase: N/A
• First received: June 24, 2008
• Last updated: August 21, 2015
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Unstable Angina

Intervention

Procedure:
• Coronary Computed Tomography Angiography
64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)
• Stress Nuclear Myocardial Perfusion Imaging
Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.

Locations

Country	Name	City	State
United States	Moses Division, Montefiore Medical Center	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine of Yeshiva University, American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Te — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary catheterization that does not lead to re-vascularization		1 year	Yes
Secondary	Length of Hospital Stay (time to discharge)		usually from hours to a few days (average about one day)	No
Secondary	Non-fatal myocardial infarction		1 year	Yes
Secondary	Death (all cause)		1 year	Yes
Secondary	Post-test renal dysfunction		usually within a few days	Yes