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Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations

NCT01262625 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2023-12-26

Study results available
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Summary

This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into alternate explanations of chest pain, and increased cost-effectiveness in comparison with use of SPECT MPI/invasive coronary angiography (ICA).

Conditions

Interventions

DEVICE

CCTA

Complete diagnostic CCTA per protocol specifications.

DEVICE

SPECT MPI/ICA

Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.

Sponsors & Collaborators

  • American College of Radiology

    lead OTHER

Principal Investigators

  • Arthur Stillman, MD, PhD · Division of Cardiothoracic Imaging, Emory University

  • Pamela K Woodard, MD · Mallinckrodt Institute of Radiology, Washington University of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-20
Primary Completion
2014-11-26
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262625 on ClinicalTrials.gov