Clinical Trial: PROspective Multicenter Imaging Study for Evaluation of Chest Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Duke University

Current 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.


Original Primary Outcome: Time to first event - composite of major CV events [ Time Frame: 2 years ]

Time to first event, using a composite of major CV events: death, MI, major complications from CV procedures or testing, unstable angina hospitalization


Current Secondary Outcome:

  • 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 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 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 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 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 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 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 ]
    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.
  • 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 ]
    Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
  • Medical Cost [ Time Frame: 90 days and 3 years cumulative ]
    Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 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 ]
    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).
  • Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale [ Time Frame: Baseline, 6 month, 12 month, 24 month ]
    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.
  • Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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 ass

    Original Secondary Outcome:

    • Death [ Time Frame: 2 years ]
      Death
    • myocardial infarction [ Time Frame: 2 years ]
      myocardial infarction
    • unstable angina hospitalization [ Time Frame: 2 years ]
      unstable angina hospitalization
    • major complications from CV procedures [ Time Frame: 2 years ]
      Major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure)
    • cumulative radiation exposure [ Time Frame: 2 years ]
      cumulative radiation exposure
    • Medical Cost [ Time Frame: 2 years ]
      Medical costs, resource use, and incremental cost effectiveness
    • quality of life [ Time Frame: 2 years ]
      health related quality of life


    Information By: Duke University

    Dates:
    Date Received: August 2, 2010
    Date Started: July 2010
    Date Completion:
    Last Updated: February 2, 2016
    Last Verified: January 2016