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

NCT ID: NCT00705458

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Angina Pectoris Unstable Angina Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CTA

Initial EKG-gated computed tomography angiography of the coronary arteries

Group Type EXPERIMENTAL

Coronary Computed Tomography Angiography

Intervention Type PROCEDURE

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

MPI

Initial nuclear stress myocardial perfusion imaging

Group Type ACTIVE_COMPARATOR

Stress Nuclear Myocardial Perfusion Imaging

Intervention Type 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.

Interventions

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Coronary Computed Tomography Angiography

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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CCTA Coronary CT Coronary CTA Coronary Artery CT Coronary Artery CTA Coronary CT Angiography CTA of the Coronary Arteries stress test nuclear stress test dual-isotope stress test sestamibi thallium myocardial perfusion imaging nuclear perfusion imaging gated SPECT nuclear cardiology

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Levsky

Associate Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda B Haramati, MD, MS

Role: STUDY_DIRECTOR

Montefiore Medical Center/Albert Einstein College of Medicine

Jeffrey M Levsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

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Moses Division, Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19577217 (View on PubMed)

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.

Reference Type RESULT
PMID: 26052677 (View on PubMed)

Other Identifiers

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MMC-07-07-197

Identifier Type: -

Identifier Source: org_study_id

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