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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01174550
First received: August 2, 2010
Last updated: February 2, 2016
Last verified: January 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Chest Pain
Interventions: Procedure: Coronary Angiography
Procedure: Stress Echocardiogram
Procedure: Nuclear Stress Test
Procedure: Exercise Electrocardiogram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Functional Diagnostic Tests

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

Anatomic Diagnostic Test

Coronary Angiography

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


Participant Flow:   Overall Study
    Functional Diagnostic Tests     Anatomic Diagnostic Test  
STARTED     5007     4996  
COMPLETED     3737     4123  
NOT COMPLETED     1270     873  
Death                 75                 74  
Lost to Follow-up                 652                 510  
Withdrawal by Subject                 543                 289  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Functional Diagnostic Tests

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

Anatomic Diagnostic Test

Coronary Angiography

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

Total Total of all reporting groups

Baseline Measures
    Functional Diagnostic Tests     Anatomic Diagnostic Test     Total  
Number of Participants  
[units: participants]
  5007     4996     10003  
Age  
[units: years]
Mean (Standard Deviation)
  60.9  (8.3)     60.7  (8.3)     60.8  (8.3)  
Gender  
[units: participants]
     
Female     2675     2595     5270  
Male     2332     2401     4733  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Primary Endpoint   [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   Medical Cost   [ Time Frame: 90 days and 3 years cumulative ]

8.  Secondary:   Quality of Life (QOL) as Measured by Duke Activity Status Index   [ Time Frame: Baseline, 6 months, 12 months 24 months ]

9.  Secondary:   Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale   [ Time Frame: Baseline, 6 month, 12 month, 24 month ]

10.  Secondary:   Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale   [ Time Frame: Baseline, 6 months, 12 months, 24 months ]

11.  Secondary:   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 ]

12.  Secondary:   Cumulative Radiation Exposure Within 90 Days   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Pamela Douglas
Organization: Duke University Medical Center
phone: 919-668-8700
e-mail: pamela.douglas@duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01174550     History of Changes
Other Study ID Numbers: Pro00019865
R01HL098237-01 ( US NIH Grant/Contract Award Number )
Study First Received: August 2, 2010
Results First Received: October 19, 2015
Last Updated: February 2, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board