Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations (RESCUE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01262625
First received: December 15, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Chest Pain
Stable Angina Pectoris, CCS Class I to III
Angina Equivalent
Coronary Artery Disease
Device: CCTA
Device: SPECT MPI/ICA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ACRIN 4701 RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Outcomes Comparison Between Group A and Group B Diagnostic Tests [ Time Frame: up to 24 Months (depends on time of trial enrollment and funding duration) ] [ Designated as safety issue: Yes ]
    To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of CAD diagnosis (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to OMT.


Secondary Outcome Measures:
  • Evaluate Prognostic Indices to Predict Outcomes [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    To evaluate the ability of available prognostic indices to predict revascularization or MACE using CCTA information and to develop new indices using the RESCUE trial data.

  • Cost, Effectiveness, and Incremental Cost-Effectiveness [ Time Frame: 6 and 12, and possibly 18 and 24 Months ] [ Designated as safety issue: No ]
    To determine the cost, effectiveness, and incremental cost-effectiveness of CCTA versus SPECT MPI/ICA in the evaluation of participants with symptoms of stable angina.

  • Outcomes Related to Symptoms and Self-Reported Health Status [ Time Frame: 6 and 12, and possibly 18 and 24 Months ] [ Designated as safety issue: Yes ]
    To compare angina symptoms and self-reported health status of participants with symptoms of stable angina undergoing CCTA as initial method of CAD diagnosis to SPECT MPI/ICA as a guide to OMT.


Estimated Enrollment: 4300
Study Start Date: January 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: CCTA Diagnostic
Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
Device: CCTA
Complete diagnostic CCTA per protocol specifications.
Other Names:
  • coronary CT
  • cardiac CT
Active Comparator: Group B: SPECT MPI/ICA Diagnostic
Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
Device: SPECT MPI/ICA
Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
Other Names:
  • nuclear medicine cardiac stress test
  • stress test
  • nuclear medicine stress testc
  • cardiac stress test
  • exercise cardiac stress test
  • pharmacologic cardiac stress test

Detailed Description:

The Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations (RESCUE) is a multi-center randomized, controlled trial responding to the need for comparative analysis of these imaging technologies and the role of OMT in clinical care. A total of 4300 patients will be randomized to CCTA or SPECT MPI/ICA for diagnostic assessment of angina at up to 80 institutions internationally. This study builds on the results of the COURAGE trial by comparing CCTA and SPECT MPI/ICA integrated into a care paradigm featuring initial treatment with OMT for patients diagnosed with CAD without significant disease in the left main coronary artery. Participants will be followed for a composite endpoint of MACE and cross-over to revascularization over a follow-up period up to two years (two to six time points depending on diagnostic results and time of enrollment into the trial). The primary endpoint of the study is a combined endpoint of occurrence of MACE and revascularization. We will calculate differences in the combined MACE/revascularization endpoint between the CCTA and SPECT MPI/ICA arms. Participant outcomes will be assessed by age, gender, comorbidity, and angina classification class at presentation. Several comparative-effectiveness analyses will be performed. We hypothesize that the CCTA arm will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into or alternate explanations of chest pain, and increased cost-effectiveness in comparison with SPECT MPI/ICA. Findings are expected to result in validation of an evolving new standard of care for patients with stable angina that takes advantage of CCTA and OMT to more cost-effectively drive appropriate care while reducing the need for invasive diagnosis and increased radiation exposure with SPECT MPI/ICA.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide a written informed consent;
  • 40 years or older;
  • Presentation with symptoms of stable angina (CCS Class I to III) or angina equivalent with or without known CAD;
  • Planned non-invasive imaging for CAD diagnosis;
  • Able to tolerate CCTA or SPECT MPI per randomization as required by protocol, to be performed at an ACRIN-qualified facility with a RESCUE-qualified scanner.

Exclusion Criteria:

  • Prior revascularization;
  • Not suitable to undergo CT with an iodinated contrast agent:

    • Known allergy-like reaction to contrast media as defined by the American College of Radiology (ACR) (see www.acr.org/SecondaryMainMenuCategories/quality_safety/contrast_manual.aspx for reaction definition) or moderate to severe allergic reactions to more than one allergen;
    • Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration;
  • Renal insufficiency at the time of enrollment, as determined by GFR 30 to 60 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration, unless permitted by the institution's policy and/or ACR guidance for risk reduction strategies (see www.acr.org/SecondaryMainMenuCategories/quality_safety/contrast_manual.aspx for guidance on contrast selection and pre-treatment strategies);
  • Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CCTA;
  • Acute ischemia;
  • Acute myocardial infarction;
  • Severe myocardial ischemia: known markedly positive exercise treadmill stress test (significant ST segment depressions or hypotensive response during stage I of the Bruce protocol);
  • Unable to suspend respiration for 15 seconds or to follow instructions to do so;
  • Unstable angina and symptoms refractory to maximal oral and intravenous medical therapy (persistent CCS Class IV);
  • History of known left ventricular ejection fraction < 45%;
  • Pulmonary edema or heart failure unresponsive to standard medical therapy;
  • Pacemaker;
  • Valvular heart disease likely to require surgery in the next 18 months;
  • Congenital heart disease or cardiomyopathy likely to affect prognosis during follow up;
  • Significant systemic hypertension (blood pressure > 200/100 mm Hg) unresponsive to medical therapy;
  • Severe noncardiovascular comorbidity limiting survival (e.g., cancer or other life threatening illness for which the patient is expected to live less than 12 months);
  • Prior imaging evaluation for this episode of symptoms (e.g., SPECT MPI or CCTA within the previous 72 hours);
  • BMI > 40 kg/m2;
  • Pregnancy or intent to become pregnant (if a female is of childbearing potential—defined as a premenopausal female capable of becoming pregnant—a pregnancy test should be done prior to enrollment).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01262625

Locations
United States, Georgia
Atlantic VA Medical Center
Decatur, Georgia, United States, 30033
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Virginia
Salem VA Medical Center
Salem, Virginia, United States, 24153
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: Arthur Stillman, MD, PhD Division of Cardiothoracic Imaging, Emory University
Principal Investigator: Pamela K Woodard, MD Mallinckrodt Institute of Radiology, Washington University of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01262625     History of Changes
Other Study ID Numbers: ACRIN 4701: RESCUE, 1R01HS019403
Study First Received: December 15, 2010
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
stable angina
recurrent chest pain
chest pain
angina equivalent
diagnosis
coronary artery disease

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 21, 2014