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PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174550
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Chest Pain
Interventions Procedure: Coronary Angiography
Procedure: Stress Echocardiogram
Procedure: Nuclear Stress Test
Procedure: Exercise Electrocardiogram
Enrollment 10003
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Functional Diagnostic Tests Anatomic Diagnostic Test
Hide Arm/Group Description

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Period Title: Overall Study
Started 5007 4996
Completed 3737 4123
Not Completed 1270 873
Reason Not Completed
Death             75             74
Lost to Follow-up             652             510
Withdrawal by Subject             543             289
Arm/Group Title Functional Diagnostic Tests Anatomic Diagnostic Test Total
Hide Arm/Group Description

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Total of all reporting groups
Overall Number of Baseline Participants 5007 4996 10003
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5007 participants 4996 participants 10003 participants
60.9  (8.3) 60.7  (8.3) 60.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5007 participants 4996 participants 10003 participants
Female
2675
  53.4%
2595
  51.9%
5270
  52.7%
Male
2332
  46.6%
2401
  48.1%
4733
  47.3%
1.Primary Outcome
Title Time to Primary Endpoint
Hide Description 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.
Time Frame 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Measure Type: Number
Unit of Measure: Percentage of participants with an event
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
2.Secondary Outcome
Title Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
Hide Description 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.
Time Frame 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Measure Type: Number
Unit of Measure: Percentage of participants with an event
90 day 0.9 1.0
6 month 1.2 1.4
12 month 1.8 1.9
18 month 2.5 2.5
24 month 2.9 2.8
30 month 3.5 3.4
36 month 4.6 3.7
42 month 5.2 5.1
3.Secondary Outcome
Title Time to Death or Myocardial Infarction (MI)
Hide Description 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.
Time Frame 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Measure Type: Number
Unit of Measure: Percentage of participants with an event
90 Days 0.3 0.6
6 months 0.4 0.9
12 months 0.8 1.2
18 months 1.3 1.8
24 months 1.7 2.0
30 months 2.2 2.7
36 months 3.3 3.0
42 months 3.9 4.2
4.Secondary Outcome
Title Time to Major Complications From Cardiovascular (CV) Procedures
Hide Description 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.
Time Frame 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Measure Type: Number
Unit of Measure: Percentage of participants with an event
90 day 0.1 0.3
6 month 0.2 0.5
12 month 0.5 0.8
18 month 1.0 1.1
24 month 1.2 1.4
30 month 1.7 1.9
36 month 2.6 2.2
42 month 3.1 3.2
5.Secondary Outcome
Title Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
Hide Description 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.
Time Frame 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Measure Type: Number
Unit of Measure: Percentage of participants with an event
90 days 4.4 5.2
6 months 4.6 5.6
12 months 5.2 6.1
18 months 5.9 6.7
24 months 6.3 6.9
30 months 6.9 7.6
36 months 8.0 7.9
42 months 8.7 9.1
6.Secondary Outcome
Title Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
Hide Description Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Time Frame Up to 90 days following participant randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Mean (Standard Error)
Unit of Measure: Percentage of events
3.4  (0.3) 4.3  (0.3)
7.Secondary Outcome
Title Medical Cost
Hide Description Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Time Frame 90 days and 3 years cumulative
Hide Outcome Measure Data
Hide Analysis Population Description
Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4818 4831
Mean (95% Confidence Interval)
Unit of Measure: Per participant cost in US dollars
90 days
2494
(2233 to 2821)
2240
(1599 to 3119)
3 years cumulative
7213
(6501 to 8156)
6586
(5683 to 7772)
8.Secondary Outcome
Title Quality of Life (QOL) as Measured by Duke Activity Status Index
Hide Description 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).
Time Frame Baseline, 6 months, 12 months 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants were limited due to budget constraints.
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 2982 3003
Median (Inter-Quartile Range)
Unit of Measure: participant score
Baseline
21.5
(10.7 to 38.2)
22.9
(10.0 to 39.5)
6 months
30.5
(10.7 to 44.7)
30.2
(15.2 to 44.7)
12 months
29.2
(13.5 to 44.7)
31.2
(15.2 to 44.7)
24 months
31.5
(16.0 to 45.5)
31.2
(16.0 to 45.5)
9.Secondary Outcome
Title Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Hide Description 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.
Time Frame Baseline, 6 month, 12 month, 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants were limited due to budget constraints.
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 2982 3003
Median (Inter-Quartile Range)
Unit of Measure: participant score
Baseline
70
(70 to 90)
80
(70 to 90)
6 month
100
(90 to 100)
100
(90 to 100)
12 month
100
(90 to 100)
100
(90 to 100)
24 month
100
(100 to 100)
100
(100 to 100)
10.Secondary Outcome
Title Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Hide Description 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.
Time Frame Baseline, 6 months, 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants were limited due to budget constraints.
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 2982 3003
Median (Inter-Quartile Range)
Unit of Measure: participant score
Baseline
58.3
(41.7 to 75.0)
58.3
(41.7 to 75.0)
6 month
83.3
(75.0 to 91.7)
83.3
(75.0 to 100)
12 month
83.3
(75.0 to 100)
91.7
(75.0 to 100)
24 month
91.7
(75 to 100)
91.7
(75.0 to 100)
11.Secondary Outcome
Title Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
Hide Description Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Time Frame 6 month, 12 month 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants were limited due to budget constraints.
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 2982 3003
Measure Type: Number
Unit of Measure: % of participants
6 months 43.3 46.5
12 months 47.3 48.8
24 months 52.1 54.3
12.Secondary Outcome
Title Cumulative Radiation Exposure Within 90 Days
Hide Description Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Diagnostic Test Functional Diagnostic Tests
Hide Arm/Group Description:

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Overall Number of Participants Analyzed 4996 5007
Median (Inter-Quartile Range)
Unit of Measure: milliSievert (mSv)
10.0
(5.6 to 17.2)
11.3
(0.0 to 13.5)
Time Frame Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Adverse Event Reporting Description Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
 
Arm/Group Title Functional Diagnostic Tests Anatomic Diagnostic Test
Hide Arm/Group Description

Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram

Stress Echocardiogram: Use of standard equipment for usual-care testing

Nuclear Stress Test: Use of standard equipment for usual-care testing

Exercise Electrocardiogram: Use of standard equipment for usual-care testing

Coronary Angiography

Coronary Angiography: Use of standard equipment for usual-care testing

All-Cause Mortality
Functional Diagnostic Tests Anatomic Diagnostic Test
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Functional Diagnostic Tests Anatomic Diagnostic Test
Affected / at Risk (%) Affected / at Risk (%)
Total   161/5007 (3.22%)   168/4996 (3.36%) 
Cardiac disorders     
Death- Cardiovascular   21/5007 (0.42%)  14/4996 (0.28%) 
Major Bleeding   3/5007 (0.06%)  3/4996 (0.06%) 
Myocardial Infarction   40/5007 (0.80%)  30/4996 (0.60%) 
Stroke   2/5007 (0.04%)  1/4996 (0.02%) 
Unstable Angina Hospitalization   41/5007 (0.82%)  61/4996 (1.22%) 
General disorders     
Death - Non cardiovascular known cause   27/5007 (0.54%)  33/4996 (0.66%) 
Death - unknown cause   27/5007 (0.54%)  27/4996 (0.54%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Functional Diagnostic Tests Anatomic Diagnostic Test
Affected / at Risk (%) Affected / at Risk (%)
Total   16/5007 (0.32%)   37/4996 (0.74%) 
Cardiac disorders     
Exercise Induced Hypotension   6/5007 (0.12%)  0/4996 (0.00%) 
Stress Induced Symptoms Related to Functional Testing   4/5007 (0.08%)  0/4996 (0.00%) 
Ventricular Tachycardia   4/5007 (0.08%)  0/4996 (0.00%) 
Hemodynamic Instability   2/5007 (0.04%)  3/4996 (0.06%) 
Any Event Potentially Related to Vasodilators   5/5007 (0.10%)  0/4996 (0.00%) 
General disorders     
Hospital Admission Not In The Primary Endpoint   5/5007 (0.10%)  0/4996 (0.00%) 
Skin and subcutaneous tissue disorders     
Mild Contrast Reaction (rash or hives)   0/5007 (0.00%)  22/4996 (0.44%) 
Extravasion of Contrast Into Surrounding Tissue   0/5007 (0.00%)  12/4996 (0.24%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pamela Douglas
Organization: Duke University Medical Center
Phone: 919-668-8700
EMail: pamela.douglas@duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01174550    
Other Study ID Numbers: Pro00019865
R01HL098237-01 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2010
First Posted: August 3, 2010
Results First Submitted: October 19, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016