Chest PainRESCUENCT01262625
Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations
A study testing CCTA and SPECT MPI/ICA in people with Chest Pain and Stable Angina Pectoris, CCS Class I to III, run by American College of Radiology at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chest Pain, Stable Angina Pectoris, CCS Class I to III, Angina Equivalent
- What is being tested?
- CCTA and SPECT MPI/ICA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlantic VA Medical Center
Decatur, Georgia, 30033
Henry Ford Hospital
Detroit, Michigan, 48202
Salem VA Medical Center
Salem, Virginia, 24153
About this study
Official title: ACRIN-4701 RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations
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).
Read the 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 using computer-aided diagnosis (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.
- Conditions
- Chest Pain, Stable Angina Pectoris, CCS Class I to III, Angina Equivalent, Coronary Artery Disease
- Being tested
- CCTA, SPECT MPI/ICA
- Keywords
- stable angina, recurrent chest pain, chest pain, angina equivalent, diagnosis, coronary artery disease
- Medical subject headings
- Chest Pain, Angina, Stable, Coronary Artery Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTADevice
Also called coronary CT, cardiac CT, coronary computed tomographic angiography
Complete diagnostic CCTA per protocol specifications.
SPECT MPI/ICADevice
Also called nuclear medicine cardiac stress test, stress test, nuclear medicine stress test, cardiac stress test
Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group A: CCTA Diagnostic | Experimental | Participants randomized to diagnostic evaluation using coronary computed tomographic angiography (CCTA) to determine therapeutic course of action. Receives: 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. Receives: Device: SPECT MPI/ICA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
AUC is a unitless measure of performance ranging form 0.5 (guessing) to 1.0 (perfect predictor) that can be thought of a the proportion of correct classifications in a 2-alternative-forced-choice experiment - and for binary outcomes, it is equivalent to the C-statistic.
It will be used to evaluate and compare the ability of available prognostic indices and SPECT-MPI % reversible defect size to predict revascularization or MACE using CCTA information:
A CCTA Modified Duke index A CCTA index including the 16 individual American Heart Association (AHA) segments A CCTA including the 16 individual AHA segments and clinical data and compare them to the SPECT % reversible defect size results
Measured: 1 year
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36+SAQ at baseline and to a subset of participants, stratified by diagnostic examination, at 12 months after enrollment to monitor angina symptoms and their impact on Quality of life.
The Short Form-36 (SF36) is a 36 item overall health status/Quality of Life collected in 8 domains. Scales are standardized with scores ranging from 0-100. Higher scores= better health status.
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item, cardiac disease-related quality-of-life measure collected in 5 domains. scales are standardized with scores ranging from 0-100. Higher scores= better health status.
Positive cardiac findings on diagnostic testing are defined as:
- 50% stenosis on CCTA or un-evaluable left main, or proximal and mid segments of all other epicardial arteries (right coronary artery, left anterior descending artery, or left circumflex artery); and
- 10% reversible defect on SPECT MPI or evidence of Transient Ischemic Dilation (TID) accompanied by ECG
Measured: baseline and 12 months
The Effectiveness of Each Arm Will be Measured in Terms of Life Years and Quality of Life Years (QALY).
International medical records will be used to determine mortality which may not be feasible at all participating international sites.
Utilities will be based on Quality of Well Being scores converted from the SF-36 assessments The analysis will be performed assuming a societal perspective and lifetime time horizon
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study start20 May 2011
- Primary completion26 Nov 2014
- Study completionFeb 2015
Why it stopped: Funding timeline completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Stillman, MD, PhD, Principal investigator, Division of Cardiothoracic Imaging, Emory UniversityPamela K Woodard, MD, Study chair, Mallinckrodt Institute of Radiology, Washington University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262625
- Sponsor's protocol ID
- ACRIN 4701 RESCUE
- Other IDs
- 1R01HS019403
- Acronym
- RESCUE
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2010
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17387127Shaw 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.
PubMed 18268144Stillman 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.
PubMed 33283579
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACRIN-4701 RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations
- ClinicalTrials.gov ID
- NCT01262625
- Acronym / sponsor ID
- RESCUE / ACRIN 4701 RESCUE
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding timeline completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Study start
- 20 May 2011 (actual)
- Primary completion
- 26 Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 using computer-aided diagnosis (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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: CCTA Diagnostic | Experimental | Device: CCTAParticipants randomized to diagnostic evaluation using coronary computed tomographic angiography (CCTA) to determine therapeutic course of action. |
| Group B: SPECT MPI/ICA Diagnostic | Active comparator | Device: SPECT MPI/ICAStandard-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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- Prior revascularization;
- Not suitable to undergo CT with an iodinated contrast agent:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTAAlso: coronary CT, cardiac CT, coronary computed tomographic angiographyComplete diagnostic CCTA per protocol specifications. | Device | Group A: CCTA Diagnostic |
| SPECT MPI/ICAAlso: nuclear medicine cardiac stress test, stress test, nuclear medicine stress test, cardiac stress testPerform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol. | Device | Group B: SPECT MPI/ICA Diagnostic |
Primary outcome
Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization)
Time frame: up to 24 Months (depends on time of trial enrollment and funding duration)
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
3 secondary outcomes
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)
Time frame: 1 year
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
Time frame: baseline and 12 months
The Effectiveness of Each Arm Will be Measured in Terms of Life Years and Quality of Life Years (QALY).
Time frame: Baseline and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17387127Boden 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.
- Background: PubMed 18268144Shaw 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.
- Derived from this study: PubMed 33283579Stillman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Stillman, MD, PhD principal investigator
Division of Cardiothoracic Imaging, Emory University
Pamela K Woodard, MD study chair
Mallinckrodt Institute of Radiology, Washington University of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCTA and SPECT MPI/ICA in people with Chest Pain and Stable Angina Pectoris, CCS Class I to III, run by American College of Radiology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) (time frame: up to 24 Months (depends on time of trial enrollment and funding duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262625, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.