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Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain (PROSPECT-CAD)

Primary Purpose

Coronary Artery Disease, Angina Pectoris, Unstable Angina

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Coronary CT angiography

Myocardial perfusion imaging

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring randomized controlled trial, controlled clinical trial, comparative effectiveness research, chest pain, angina pectoris, non-invasive cardiac imaging, nuclear stress testing, coronary CT angiography, coronary catheterization, coronary revascularization

Eligibility Criteria

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

Inclusion Criteria:

patient admitted for chest pain / pressure or other suggestive symptoms
patient has known coronary artery disease (with or without prior revascularization)
patient has clinical need for non-invasive cardiac evaluation

Exclusion Criteria:

evidence of ongoing myocardial infarction or hemodynamic instability
ischemia on EKG (greater than 1mm ST segment deviation)
contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
heart rhythm precluding EKG gating
pregnancy

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial coronary CT angiography

Initial nuclear stress test

Arm Description

EKG-gated, computed tomography angiography of the coronary arteries during heart rate control

Stress radionuclide myocardial perfusion imaging

Outcomes

Primary Outcome Measures

Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass

Secondary Outcome Measures

Length of hospital stay (time to discharge)

Number of participants that have a subsequent non-fatal myocardial infarction

Number of participants that die due to any cause

Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization

Full Information

NCT ID

NCT01106612

First Posted

April 12, 2010

Last Updated

April 7, 2015

Sponsor

Montefiore Medical Center

Collaborators

Albert Einstein College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01106612

Brief Title

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

Acronym

PROSPECT-CAD

Official Title

A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

low recruitment

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 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

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 known 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

randomized controlled trial, controlled clinical trial, comparative effectiveness research, chest pain, angina pectoris, non-invasive cardiac imaging, nuclear stress testing, coronary CT angiography, coronary catheterization, coronary revascularization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Initial coronary CT angiography

Arm Type

Experimental

Arm Description

EKG-gated, computed tomography angiography of the coronary arteries during heart rate control

Arm Title

Initial nuclear stress test

Arm Type

Active Comparator

Arm Description

Stress radionuclide myocardial perfusion imaging

Intervention Type

Procedure

Intervention Name(s)

Coronary CT angiography

Other Intervention Name(s)

Coronary CTA, Coronary CT, CTA of the coronary arteries, CT of the coronary arteries, CTA, CCTA, Cardiac CTA, Cardiac CT, CT Angiography of the coronary arteries, Computed tomography angiography of the coronary arteries

Intervention Description

EKG-gated, computed tomography angiography of the coronary arteries during heart rate control

Intervention Type

Procedure

Intervention Name(s)

Myocardial perfusion imaging

Other Intervention Name(s)

MPI, MPS, stress MPI, stress MPS, radionuclide MPI, stress nuclear, nuclear stress, nuclear stress test, nuclear stress testing, nuclear cardiology, nuclear perfusion imaging, nuclear myocardial perfusion imaging, myocardial perfusion

Intervention Description

Stress radionuclide myocardial perfusion imaging

Primary Outcome Measure Information:

Title

Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Length of hospital stay (time to discharge)

Time Frame

1 month

Title

Number of participants that have a subsequent non-fatal myocardial infarction

Time Frame

1 year

Title

Number of participants that die due to any cause

Time Frame

1 year

Title

Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient admitted for chest pain / pressure or other suggestive symptoms patient has known coronary artery disease (with or without prior revascularization) patient has clinical need for non-invasive cardiac evaluation Exclusion Criteria: evidence of ongoing myocardial infarction or hemodynamic instability ischemia on EKG (greater than 1mm ST segment deviation) contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction) heart rhythm precluding EKG gating pregnancy

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

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

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

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