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

Primary Purpose

Coronary Artery Disease, Angina Pectoris, Unstable Angina

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Coronary Computed Tomography Angiography

Stress Nuclear Myocardial Perfusion Imaging

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring stress myocardial perfusion imaging, coronary computed tomography angiography

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Moses Division, Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CTA

MPI

Arm Description

Initial EKG-gated computed tomography angiography of the coronary arteries

Initial nuclear stress myocardial perfusion imaging

Outcomes

Primary Outcome Measures

Coronary catheterization that does not lead to re-vascularization

Secondary Outcome Measures

Length of Hospital Stay (time to discharge)

Non-fatal myocardial infarction

Death (all cause)

Post-test renal dysfunction

Full Information

NCT ID

NCT00705458

First Posted

June 24, 2008

Last Updated

August 21, 2015

Sponsor

Montefiore Medical Center

Collaborators

American Heart Association, Albert Einstein College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00705458

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

Collaborators

American Heart Association, Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

stress myocardial perfusion imaging, coronary computed tomography angiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CTA

Arm Type

Experimental

Arm Description

Initial EKG-gated computed tomography angiography of the coronary arteries

Arm Title

MPI

Arm Type

Active Comparator

Arm Description

Initial nuclear stress myocardial perfusion imaging

Intervention Type

Procedure

Intervention Name(s)

Coronary Computed Tomography Angiography

Other Intervention Name(s)

CCTA, Coronary CT, Coronary CTA, Coronary Artery CT, Coronary Artery CTA, Coronary CT Angiography, CTA of the Coronary Arteries

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Stress Nuclear Myocardial Perfusion Imaging

Other Intervention Name(s)

stress test, nuclear stress test, dual-isotope stress test, sestamibi, thallium, myocardial perfusion imaging, nuclear perfusion imaging, gated SPECT, nuclear cardiology

Intervention Description

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.

Primary Outcome Measure Information:

Title

Coronary catheterization that does not lead to re-vascularization

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Length of Hospital Stay (time to discharge)

Time Frame

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

Title

Non-fatal myocardial infarction

Time Frame

1 year

Title

Death (all cause)

Time Frame

1 year

Title

Post-test renal dysfunction

Time Frame

usually within a few days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda B Haramati, MD, MS

Organizational Affiliation

Montefiore Medical Center/Albert Einstein College of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jeffrey M Levsky, MD, PhD

Organizational Affiliation

Montefiore Medical Center/Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moses Division, Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19577217

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.

Results Reference

background

PubMed Identifier

26052677

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.

Results Reference

result

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

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