Status:
TERMINATED
Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations
Lead Sponsor:
American College of Radiology
Conditions:
Chest Pain
Stable Angina Pectoris, CCS Class I to III
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) m...
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...
Eligibility Criteria
Inclusion
- 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
- 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 (ST) \[significant ST segment depressions or hypotensive response during stage I of the Bruce protocol\];
- 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).
Key Trial Info
Start Date :
May 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT01262625
Start Date
May 20 2011
End Date
February 1 2015
Last Update
December 26 2023
Active Locations (3)
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1
Atlantic VA Medical Center
Decatur, Georgia, United States, 30033
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Salem VA Medical Center
Salem, Virginia, United States, 24153