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

NCT00705458 | Completed DMC

• 1 other identifier: MMC-07-07-197
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Angina Pectoris; Unstable Angina; Acute Coronary Syndrome

Keywords

stress myocardial perfusion imaging; coronary computed tomography angiography

Outcome Measures

Primary Outcomes (1)

• Coronary catheterization that does not lead to re-vascularization

  1 year

Secondary Outcomes (4)

• Length of Hospital Stay (time to discharge)

  usually from hours to a few days (average about one day)

• Non-fatal myocardial infarction

  1 year

• Death (all cause)

  1 year

• Post-test renal dysfunction

  usually within a few days

Study Arms (2)

CTA

EXPERIMENTAL

Initial EKG-gated computed tomography angiography of the coronary arteries

Procedure: Coronary Computed Tomography Angiography

MPI

ACTIVE COMPARATOR

Initial nuclear stress myocardial perfusion imaging

Procedure: Stress Nuclear Myocardial Perfusion Imaging

Interventions

Coronary Computed Tomography Angiography PROCEDURE

64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)

Also known as: CCTA, Coronary CT, Coronary CTA, Coronary Artery CT, Coronary Artery CTA, Coronary CT Angiography, CTA of the Coronary Arteries

CTA

Stress Nuclear Myocardial Perfusion Imaging PROCEDURE

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.

Also known as: stress test, nuclear stress test, dual-isotope stress test, sestamibi, thallium, myocardial perfusion imaging, nuclear perfusion imaging, gated SPECT, nuclear cardiology

MPI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• American Heart Association: collaborator
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Moses Division, Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (2)

• 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.

  PMID: 19577217 BACKGROUND

• 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.

  PMID: 26052677 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Angina, Unstable; Acute Coronary Syndrome

Interventions

Exercise Test; Technetium Tc 99m Sestamibi; Thallium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Linda B Haramati, MD, MS

  Montefiore Medical Center/Albert Einstein College of Medicine

  STUDY DIRECTOR

• Jeffrey M Levsky, MD, PhD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)