Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations

NCT01262625 | Terminated Results DMC

• 2 other identifiers: ACRIN 4701 RESCUE1R01HS019403
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 3

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) 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

Chest Pain; Stable Angina Pectoris, CCS Class I to III; Angina Equivalent; Coronary Artery Disease

Keywords

stable angina; recurrent chest pain; chest pain; angina equivalent; diagnosis; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization)

  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 computer-aided diagnosis (CAD) (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to Optimal Medical Therapy (OMT) alone. The analysis was conducted from an intent-to-treat perspective

  up to 24 Months (depends on time of trial enrollment and funding duration)

Secondary Outcomes (3)

• Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC)

  1 year

• Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score

  baseline and 12 months

• The Effectiveness of Each Arm Will be Measured in Terms of Life Years and Quality of Life Years (QALY).

  Baseline and 1 year

Study Arms (2)

Group A: CCTA Diagnostic

EXPERIMENTAL

Participants randomized to diagnostic evaluation using coronary computed tomographic angiography (CCTA) to determine therapeutic course of action.

Device: CCTA

Group B: SPECT MPI/ICA Diagnostic

ACTIVE COMPARATOR

Standard-of-care diagnostic assessment using single photon emission computed tomography myocardial perfusion imaging (SPECT MPI), possibly followed by diagnostic invasive coronary angiography (ICA) dependent on SPECT MPI results.

Device: SPECT MPI/ICA

Interventions

CCTA DEVICE

Complete diagnostic CCTA per protocol specifications.

Also known as: coronary CT, cardiac CT, coronary computed tomographic angiography

Group A: CCTA Diagnostic

SPECT MPI/ICA DEVICE

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

Also known as: nuclear medicine cardiac stress test, stress test, nuclear medicine stress test, cardiac stress test, exercise cardiac stress test, pharmacologic cardiac stress test, single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)

Group B: SPECT MPI/ICA Diagnostic

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide a written informed consent;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• American College of Radiology: lead

Study Sites (3)

Atlantic VA Medical Center

Decatur, Georgia, 30033, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Related Publications (3)

• Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

  PMID: 17387127 BACKGROUND

• Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.

  PMID: 18268144 BACKGROUND

• Stillman AE, Gatsonis C, Lima JAC, Liu T, Snyder BS, Cormack J, Malholtra V, Schnall MD, Udelson JE, Hoffmann U, Woodard PK; RESCUE investigators *. Coronary Computed Tomography Angiography Compared With Single Photon Emission Computed Tomography Myocardial Perfusion Imaging as a Guide to Optimal Medical Therapy in Patients Presenting With Stable Angina: The RESCUE Trial. J Am Heart Assoc. 2020 Dec 15;9(24):e017993. doi: 10.1161/JAHA.120.017993. Epub 2020 Dec 5.

  PMID: 33283579 DERIVED

MeSH Terms

Conditions

Chest Pain; Angina, Stable; Coronary Artery Disease; Disease

Interventions

Exercise Test; Tomography, Emission-Computed, Single-Photon; Myocardial Perfusion Imaging

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Cardiac Imaging Techniques; Perfusion Imaging

Results Point of Contact

• Title: Director Clinical Research Administration
• Organization: American College of Radiology

info@acr.org

215-574-3150

Study Officials

• Arthur Stillman, MD, PhD

  Division of Cardiothoracic Imaging, Emory University

  PRINCIPAL INVESTIGATOR

• Pamela K Woodard, MD

  Mallinckrodt Institute of Radiology, Washington University of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized, controlled, diagnostic, multicenter trial will follow participants at 6-month intervals for up to 24 months to determine the incidence of MACE, defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization.

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: May 20, 2011
• Primary Completion: November 26, 2014
• Study Completion: February 1, 2015
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Locations

US (3)