Chest PainPROMISENCT01174550

PROspective Multicenter Imaging Study for Evaluation of Chest Pain

A study testing Coronary Angiography, Stress Echocardiogram and Nuclear Stress Test in people with Chest Pain, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Chest Pain
What is being tested?: Coronary Angiography, Stress Echocardiogram and Nuclear Stress Test
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10,003 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Oct 2014
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
no prior evaluation for this episode of symptoms
planned non-invasive testing for diagnosis
men age ≥55 years
men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
women age ≥65 years

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women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
Serum creatinine ≤ 1.5 mg/dL within the past 90 days
Negative urine/serum pregnancy test for female subjects of child-bearing potential

Who cannot join

Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)
Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel
Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months
Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms
Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy
Life expectancy < 2 years
Unable to provide written informed consent or participate in long-term follow-up

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27701

Other trials in United States

About this study

Official title: PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial

A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.

Read the detailed description

Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.

Conditions: Chest Pain
Being tested: Coronary Angiography, Stress Echocardiogram, Nuclear Stress Test, Exercise Electrocardiogram
Keywords: chest pain, coronary artery disease, CAD
Medical subject headings: Chest Pain, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronary AngiographyProcedure or surgery
Use of standard equipment for usual-care testing
Stress EchocardiogramProcedure or surgery
Use of standard equipment for usual-care testing
Nuclear Stress TestProcedure or surgery
Use of standard equipment for usual-care testing
Exercise ElectrocardiogramProcedure or surgery
Use of standard equipment for usual-care testing

Study groups in NCT01174550
Study group	Role	What they receive
Functional diagnostic tests	Active comparator	Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Receives: Procedure: Stress Echocardiogram; Procedure: Nuclear Stress Test; Procedure: Exercise Electrocardiogram
Anatomic diagnostic test	Active comparator	Coronary Angiography Receives: Procedure: Coronary Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Primary Endpoint
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Measured: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Secondary outcomes (11)

Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Measured: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Death or Myocardial Infarction (MI)
Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Measured: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Major Complications From Cardiovascular (CV) Procedures
Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Measured: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Measured: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Measured: Up to 90 days following participant randomization
Medical Cost
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Measured: 90 days and 3 years cumulative
Quality of Life (QOL) as Measured by Duke Activity Status Index
Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Measured: Baseline, 6 months, 12 months 24 months
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \& less frequent, condition has less impact on activities, increased satisfaction with treatment, \& perception of disease has less impact on interpersonal relationships.
Measured: Baseline, 6 month, 12 month, 24 month
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \& less frequent, condition has less impact on activities, increased satisfaction with treatment, \& perception of disease has less impact on interpersonal relationships.
Measured: Baseline, 6 months, 12 months, 24 months
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Measured: 6 month, 12 month 24 month
Cumulative Radiation Exposure Within 90 Days
Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Oct 2014

First posted3 Aug 2010 (estimated)
Study startJul 2010
Primary completionOct 2014
Study completionOct 2014

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 (36)Papers the sponsor has linked to this study.
Other trials for Chest PainStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 10,003 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01174550
Sponsor's protocol ID: Pro00019865
Other IDs: R01HL098237-01
Acronym: PROMISE
Status last verified: Jan 2016
First submitted: 2 Aug 2010
Last updated: 29 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Data will be submitted to the NHLBI according to their guidelines which state"The data sets must be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the PO for review prior to release."

Publications

Brendel JM, Mayrhofer T, Kerkovits NM, Kolossvary M, Ersozlu S, Alhanti B, Corey KE, Pagidipati N, Shah SH, Meyersohn NM, Ferencik M, Lu MT, Lamon-Fava S, Hoffmann U, Douglas PS, Foldyna B. Hepatic Steatosis Is Associated With Increased Cardiovascular Risk Through Adverse Coronary Plaque Composition. Clin Gastroenterol Hepatol. 2026 May 20:S1542-3565(26)00326-5. doi: 10.1016/j.cgh.2026.04.022. Online ahead of print.
PubMed 42167630
Brendel JM, Mayrhofer T, Karady J, Kolossvary M, Kerkovits NM, Langenbach IL, Jung M, Kelsey MD, Langenbach MC, Pagidipati N, Shah SH, Lu MT, Ferencik M, Douglas PS, Foldyna B. Risk in Women Emerges at Lower Coronary Plaque Burden Than in Men: PROMISE Trial. Circ Cardiovasc Imaging. 2026 Mar;19(3):e019011. doi: 10.1161/CIRCIMAGING.125.019011. Epub 2026 Feb 23.
PubMed 41725544
Karady J, Mayrhofer T, Brendel JM, Kolossvary M, Langenbach M, Langenbach I, Baliyan V, Sturniolo AK, Pagidipati N, Lu MT, Ferencik M, Shah S, Douglas PS, Foldyna B. Prognostic Value of Plaque Volume in Patients With First Diagnosis of Coronary Artery Disease: A Substudy of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2026 Mar 1;11(3):259-267. doi: 10.1001/jamacardio.2025.5520.
PubMed 41670958
Douglas PS, Stebbins A, Foldyna B, Patel MR, Mark DB, Lu MT, Hoffmann U, Shah SH, Martinez B, Alhanti B, Pagidipati N. Survival After Initial Stress Testing vs Anatomic Testing in Suspected Coronary Artery Disease: Long-Term Follow-Up of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1050-1054. doi: 10.1001/jamacardio.2025.2882.
PubMed 40864459
Rasmussen LD, Sikjaer M, Soby JH, Pedersen OB, Westra J, Efthekhari A, Christiansen EH, Foldyna B, Williams MC, Dweck MR, Newby DE, Douglas PS, Bottcher M, Winther S. Dual probability approach for risk adjustment in patients with a low clinical likelihood of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2025 Aug 29;26(9):1507-1517. doi: 10.1093/ehjci/jeaf193.
PubMed 40590244
O'Toole T, Shah NP, Giamberardino SN, Kwee LC, Voora D, McGarrah RW, Ferencik M, Lu MT, Kraus WE, Foldyna B, Douglas PS, Shah SH, Pagidipati NJ. Association Between Lipoprotein(a) and Obstructive Coronary Artery Disease and High-Risk Plaque: Insights From the PROMISE Trial. Am J Cardiol. 2024 Nov 15;231:40-47. doi: 10.1016/j.amjcard.2024.09.006. Epub 2024 Sep 6.
PubMed 39245334
McGarrah RW, Ferencik M, Giamberardino SN, Hoffmann U, Foldyna B, Karady J, Ginsburg GS, Kraus WE, Douglas PS, Shah SH. Lipoprotein Subclasses Associated With High-Risk Coronary Atherosclerotic Plaque: Insights From the PROMISE Clinical Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e026662. doi: 10.1161/JAHA.122.026662. Epub 2022 Dec 24.
PubMed 36565187
Karady J, Ferencik M, Mayrhofer T, Meyersohn NM, Bittner DO, Staziaki PV, Szilveszter B, Hallett TR, Lu MT, Puchner SB, Simon TG, Foldyna B, Ginsburg GS, McGarrah RW, Voora D, Shah SH, Douglas PS, Hoffmann U, Corey KE. Risk factors for cardiovascular disease among individuals with hepatic steatosis. Hepatol Commun. 2022 Dec;6(12):3406-3420. doi: 10.1002/hep4.2090. Epub 2022 Oct 25.
PubMed 36281983
Ferencik M, Mayrhofer T, Lu MT, Bittner DO, Emami H, Puchner SB, Meyersohn NM, Ivanov AV, Adami EC, Voora D, Ginsburg GS, Januzzi JL, Douglas PS, Hoffmann U. Coronary Atherosclerosis, Cardiac Troponin, and Interleukin-6 in Patients With Chest Pain: The PROMISE Trial Results. JACC Cardiovasc Imaging. 2022 Aug;15(8):1427-1438. doi: 10.1016/j.jcmg.2022.03.016. Epub 2022 May 11.
PubMed 35926901
Lowenstern A, Alexander KP, Pagidipati NJ, Hill CL, Pellikka PA, Cooper LS, Alhanti B, Hoffmann U, Mark DB, Douglas PS. Presenting Symptoms in Patients Undergoing Coronary Artery Disease Evaluation: Association With Noninvasive Test Results and Clinical Outcomes in the PROMISE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008298. doi: 10.1161/CIRCOUTCOMES.121.008298. Epub 2022 Apr 4.
PubMed 35369715
Fordyce CB, Hill CL, Mark DB, Alhanti B, Pellikka PA, Hoffmann U, Patel MR, Douglas PS; PROMISE Investigators. Physician judgement in predicting obstructive coronary artery disease and adverse events in chest pain patients. Heart. 2022 May 12;108(11):860-867. doi: 10.1136/heartjnl-2021-320275.
PubMed 35110385
Kammerlander AA, Mayrhofer T, Ferencik M, Pagidipati NJ, Karady J, Ginsburg GS, Lu MT, Bittner DO, Puchner SB, Bihlmeyer NA, Meyersohn NM, Emami H, Shah SH, Douglas PS, Hoffmann U; PROMISE Investigators. Association of Metabolic Phenotypes With Coronary Artery Disease and Cardiovascular Events in Patients With Stable Chest Pain. Diabetes Care. 2021 Apr;44(4):1038-1045. doi: 10.2337/dc20-1760. Epub 2021 Feb 8.
PubMed 33558267
Meyersohn NM, Mayrhofer T, Corey KE, Bittner DO, Staziaki PV, Szilveszter B, Hallett T, Lu MT, Puchner SB, Simon TG, Foldyna B, Voora D, Ginsburg GS, Douglas PS, Hoffmann U, Ferencik M. Association of Hepatic Steatosis With Major Adverse Cardiovascular Events, Independent of Coronary Artery Disease. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1480-1488.e14. doi: 10.1016/j.cgh.2020.07.030. Epub 2020 Jul 21.
PubMed 32707340
Goyal A, Pagidipati N, Hill CL, Alhanti B, Udelson JE, Picard MH, Pellikka PA, Hoffmann U, Mark DB, Douglas PS. Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial. Circ Cardiovasc Imaging. 2020 Apr;13(4):e009986. doi: 10.1161/CIRCIMAGING.119.009986. Epub 2020 Apr 9.
PubMed 32268807
Lowenstern A, Alexander KP, Hill CL, Alhanti B, Pellikka PA, Nanna MG, Mehta RH, Cooper LS, Bullock-Palmer RP, Hoffmann U, Douglas PS. Age-Related Differences in the Noninvasive Evaluation for Possible Coronary Artery Disease: Insights From the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Trial. JAMA Cardiol. 2020 Feb 1;5(2):193-201. doi: 10.1001/jamacardio.2019.4973.
PubMed 31738382

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial
ClinicalTrials.gov ID: NCT01174550
Acronym / sponsor ID: PROMISE / Pro00019865
Conditions: Chest Pain
Keywords: chest pain, coronary artery disease, CAD
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,003 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jul 2010
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 3 Aug 2010 (estimated)
Results: Posted 29 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Functional diagnostic tests	Active comparator	Procedure: Stress Echocardiogram, Procedure: Nuclear Stress Test, Procedure: Exercise ElectrocardiogramStress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Anatomic diagnostic test	Active comparator	Procedure: Coronary AngiographyCoronary Angiography

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
no prior evaluation for this episode of symptoms
planned non-invasive testing for diagnosis
men age ≥55 years
men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia

Key exclusion criteria (8 listed)

Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)
Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel
Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months
Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms

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
Coronary AngiographyUse of standard equipment for usual-care testing	Procedure or surgery	Anatomic diagnostic test
Stress EchocardiogramUse of standard equipment for usual-care testing	Procedure or surgery	Functional diagnostic tests
Nuclear Stress TestUse of standard equipment for usual-care testing	Procedure or surgery	Functional diagnostic tests
Exercise ElectrocardiogramUse of standard equipment for usual-care testing	Procedure or surgery	Functional diagnostic tests

Primary outcome

Time to Primary Endpoint
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

11 secondary outcomes

Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Death or Myocardial Infarction (MI)
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Major Complications From Cardiovascular (CV) Procedures
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
Time frame: Up to 90 days following participant randomization
Medical Cost
Time frame: 90 days and 3 years cumulative
Quality of Life (QOL) as Measured by Duke Activity Status Index
Time frame: Baseline, 6 months, 12 months 24 months
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Time frame: Baseline, 6 month, 12 month, 24 month
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Time frame: Baseline, 6 months, 12 months, 24 months
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
Time frame: 6 month, 12 month 24 month
Cumulative Radiation Exposure Within 90 Days
Time frame: 90 days

Results and safety

Results posted to the registry on 29 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Functional Diagnostic Tests	5,007	3,737
Anatomic Diagnostic Test	4,996	4,123

Primary outcome: Time to Primary Endpoint

Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months. Number. Unit: Percentage of participants with an event

Measure	Anatomic Diagnostic Test n = 4996	Functional Diagnostic Tests n = 5007
90 days	1.0	1.1
6 months	1.2	1.4
12 months	1.8	1.9
18 months	2.5	2.6
24 months	2.9	2.8
30 months	3.5	3.5
36 months	4.6	3.8
42 months	5.3	5.1

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Functional Diagnostic Tests	161 of 5,007 (3.2%)	16 of 5,007 (0.3%)	Not reported
Anatomic Diagnostic Test	168 of 4,996 (3.4%)	37 of 4,996 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42167630Brendel JM, Mayrhofer T, Kerkovits NM, Kolossvary M, Ersozlu S, Alhanti B, Corey KE, Pagidipati N, Shah SH, Meyersohn NM, Ferencik M, Lu MT, Lamon-Fava S, Hoffmann U, Douglas PS, Foldyna B. Hepatic Steatosis Is Associated With Increased Cardiovascular Risk Through Adverse Coronary Plaque Composition. Clin Gastroenterol Hepatol. 2026 May 20:S1542-3565(26)00326-5. doi: 10.1016/j.cgh.2026.04.022. Online ahead of print.
Derived from this study: PubMed 41725544Brendel JM, Mayrhofer T, Karady J, Kolossvary M, Kerkovits NM, Langenbach IL, Jung M, Kelsey MD, Langenbach MC, Pagidipati N, Shah SH, Lu MT, Ferencik M, Douglas PS, Foldyna B. Risk in Women Emerges at Lower Coronary Plaque Burden Than in Men: PROMISE Trial. Circ Cardiovasc Imaging. 2026 Mar;19(3):e019011. doi: 10.1161/CIRCIMAGING.125.019011. Epub 2026 Feb 23.
Derived from this study: PubMed 41670958Karady J, Mayrhofer T, Brendel JM, Kolossvary M, Langenbach M, Langenbach I, Baliyan V, Sturniolo AK, Pagidipati N, Lu MT, Ferencik M, Shah S, Douglas PS, Foldyna B. Prognostic Value of Plaque Volume in Patients With First Diagnosis of Coronary Artery Disease: A Substudy of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2026 Mar 1;11(3):259-267. doi: 10.1001/jamacardio.2025.5520.
Derived from this study: PubMed 40864459Douglas PS, Stebbins A, Foldyna B, Patel MR, Mark DB, Lu MT, Hoffmann U, Shah SH, Martinez B, Alhanti B, Pagidipati N. Survival After Initial Stress Testing vs Anatomic Testing in Suspected Coronary Artery Disease: Long-Term Follow-Up of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1050-1054. doi: 10.1001/jamacardio.2025.2882.
Derived from this study: PubMed 40590244Rasmussen LD, Sikjaer M, Soby JH, Pedersen OB, Westra J, Efthekhari A, Christiansen EH, Foldyna B, Williams MC, Dweck MR, Newby DE, Douglas PS, Bottcher M, Winther S. Dual probability approach for risk adjustment in patients with a low clinical likelihood of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2025 Aug 29;26(9):1507-1517. doi: 10.1093/ehjci/jeaf193.
Derived from this study: PubMed 39245334O'Toole T, Shah NP, Giamberardino SN, Kwee LC, Voora D, McGarrah RW, Ferencik M, Lu MT, Kraus WE, Foldyna B, Douglas PS, Shah SH, Pagidipati NJ. Association Between Lipoprotein(a) and Obstructive Coronary Artery Disease and High-Risk Plaque: Insights From the PROMISE Trial. Am J Cardiol. 2024 Nov 15;231:40-47. doi: 10.1016/j.amjcard.2024.09.006. Epub 2024 Sep 6.
Derived from this study: PubMed 36565187McGarrah RW, Ferencik M, Giamberardino SN, Hoffmann U, Foldyna B, Karady J, Ginsburg GS, Kraus WE, Douglas PS, Shah SH. Lipoprotein Subclasses Associated With High-Risk Coronary Atherosclerotic Plaque: Insights From the PROMISE Clinical Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e026662. doi: 10.1161/JAHA.122.026662. Epub 2022 Dec 24.
Derived from this study: PubMed 36281983Karady J, Ferencik M, Mayrhofer T, Meyersohn NM, Bittner DO, Staziaki PV, Szilveszter B, Hallett TR, Lu MT, Puchner SB, Simon TG, Foldyna B, Ginsburg GS, McGarrah RW, Voora D, Shah SH, Douglas PS, Hoffmann U, Corey KE. Risk factors for cardiovascular disease among individuals with hepatic steatosis. Hepatol Commun. 2022 Dec;6(12):3406-3420. doi: 10.1002/hep4.2090. Epub 2022 Oct 25.
Derived from this study: PubMed 35926901Ferencik M, Mayrhofer T, Lu MT, Bittner DO, Emami H, Puchner SB, Meyersohn NM, Ivanov AV, Adami EC, Voora D, Ginsburg GS, Januzzi JL, Douglas PS, Hoffmann U. Coronary Atherosclerosis, Cardiac Troponin, and Interleukin-6 in Patients With Chest Pain: The PROMISE Trial Results. JACC Cardiovasc Imaging. 2022 Aug;15(8):1427-1438. doi: 10.1016/j.jcmg.2022.03.016. Epub 2022 May 11.
Derived from this study: PubMed 35369715Lowenstern A, Alexander KP, Pagidipati NJ, Hill CL, Pellikka PA, Cooper LS, Alhanti B, Hoffmann U, Mark DB, Douglas PS. Presenting Symptoms in Patients Undergoing Coronary Artery Disease Evaluation: Association With Noninvasive Test Results and Clinical Outcomes in the PROMISE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008298. doi: 10.1161/CIRCOUTCOMES.121.008298. Epub 2022 Apr 4.
Derived from this study: PubMed 35110385Fordyce CB, Hill CL, Mark DB, Alhanti B, Pellikka PA, Hoffmann U, Patel MR, Douglas PS; PROMISE Investigators. Physician judgement in predicting obstructive coronary artery disease and adverse events in chest pain patients. Heart. 2022 May 12;108(11):860-867. doi: 10.1136/heartjnl-2021-320275.
Derived from this study: PubMed 33558267Kammerlander AA, Mayrhofer T, Ferencik M, Pagidipati NJ, Karady J, Ginsburg GS, Lu MT, Bittner DO, Puchner SB, Bihlmeyer NA, Meyersohn NM, Emami H, Shah SH, Douglas PS, Hoffmann U; PROMISE Investigators. Association of Metabolic Phenotypes With Coronary Artery Disease and Cardiovascular Events in Patients With Stable Chest Pain. Diabetes Care. 2021 Apr;44(4):1038-1045. doi: 10.2337/dc20-1760. Epub 2021 Feb 8.
Individual participant dataSharing planned: Yes. Data will be submitted to the NHLBI according to their guidelines which state"The data sets must be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the PO for review prior to release."

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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.

Pamela S Douglas, MD principal investigator

Duke Clinical Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography, Stress Echocardiogram and Nuclear Stress Test in people with Chest Pain, run by Duke University at 1 site 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 29 Feb 2016). 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 to Primary Endpoint (time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months). 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 NCT01174550, which also lists 36 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 29 Feb 2016.