PROTOCOL SPECIFIC MATERIALS
ACRIN 4701 RESCUE Minimize

RESCUE: Randomized Evaluation of Patients with Stable Angina
Comparing Utilization of Diagnostic Examinations


Protocol Documents:

Protocol-ACRIN 4701 RESCUE Administrative Update to Amendment 1, v5.4.11 [PDF]

SOC-ACRIN 4701 RESCUE Administrative Update, 5.20.12 [PDF]

SOC-ACRIN 4701 RESCUE Amendment 1, 5.4.11 [PDF]

Informed Consent-ACRIN 4701 RESCUE Administrative Update to Amendment 1, v5.4.11 [DOC]

RESCUE Eligibility Checklist [DOC]

RESCUE Protocol Summary [DOC]

MR Form: Authorization to Release/Disclose Medical Records Template (Amendment 1) [DOC]
(To be completed by participant at time of consent for sites using ACRIN for medical record procurement. 
Please forward along with the PC "Participant Contact Information Sheet" to ACRIN Data Management
at 215-940-8922.  This form provides ACRIN authorization for medical chart procurement).

PC Form: Participant Contact Information Sheet (Amendment 1) [PDF]
(To be completed by all participants at time of consent: Foreign sites are not participating
in the Quality-of-Life [QoL] sub-study and will maintain it on site only. VA sites will use this
form as a worksheet and will maintain it on site only. All other US domestic sites, upon
registration, should forward this form to: 1) ACRIN Data Management to allow identification
for medical chart procurement requests and 2) Brown University for use in the QoL
sub-study at 12 months.)

Principal Investigator: Arthur Stillman, MD, PhD 
                                       
Status: In Follow-up

Overview:  The RESCUE trial is funded by a grant for comparative-effectiveness research from
the Agency for Healthcare Research and Quality (www.ahrq.gov). This randomized, controlled,
diagnostic, multicenter, phase III trial will assess two imaging technologies--coronary computed
tomography angiography (CCTA) and single photon emission computed tomography (SPECT)
myocardial perfusion imaging (MPI)--in diagnosing cardiac disease in patients with stable angina
or angina equivalent. Results from diagnostic imaging assessment will guide subsequent
therapeutic approach. Participants with positive cardiac findings on diagnosis will be guided
to optimal medical therapy (OMT) or diagnostic invasive coronary angiography (ICA) and possible
revascularization, depending on extent and location of disease. Participants will be followed
to collect healthcare utilization data, cardiac events, and quality-of-life questionnaires. 

Main Objective: The primary endpoint of the study is a combined endpoint of occurrence of major
adverse cardiac events (MACE), comprising cardiac-related death or acute myocardial infarction,
and revascularization. We will calculate differences in the combined MACE/revascularization
endpoint between the CCTA and SPECT MPI arms.

Participants: Patients 40 years and older presenting to ACRIN-qualified institutions with symptoms
of stable angina CCS Class I to III or angina equivalent, with or without known coronary artery
disease (CAD), and eligible to undergo non-invasive imaging for diagnosis may enroll into the study.

Study Design Summary: A total of 4300 patients will be randomized to CCTA or SPECT MPI/ICA for
diagnostic assessment at up to 80 institutions internationally. All participants diagnosed with CAD
by either strategy will be treated initially by OMT unless there is evidence of significant left main
CAD (≥ 50% stenosis) or markedly abnormal stress test, in which case they will undergo ICA and
possibly revascularization as is standard practice. Follow up at the site level will comprise telephone
participant/proxy contact at 2 weeks and 2 months after enrollment only for participants who have
positive cardiac findings on diagnostic CCTA or SPECT MPI. All participants (or their proxies) will be
contacted by telephone for additional medical information at 6-month intervals after enrollment for
up to 24 months. Number of time points and duration of follow up depend on diagnostic results and
timing of enrollment, respectively. Participant follow up will continue with medical records abstraction
in the subset of participants who self-report MACE, revascularization, cardiac-related visits, or visits
related to incidental findings associated with the diagnostic tests.

PROMISE and RESCUE Trials
Click on "FAQ" to obtain the frequently asked questions document about the PROMISE and RESCUE trials.

FAQ [DOC]

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