PRYME: Prevalence and Long-term Impact of Non-atherosclerotic CAD

Sponsor
Cardiology Research UBC (Other)
Overall Status
Completed
CT.gov ID
NCT01479140
Collaborator
University of British Columbia (Other)
160
1
109.4
1.5

Study Details

Study Description

Brief Summary

Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD) among young women, the majority of these abnormalities were misdiagnosed in this population, and thus treatments were not targeted adequately in this patient population. Furthermore, the short and long-term cardiovascular outcomes of young women with NACAD have not been evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to further evaluate this population. We propose to evaluate young women (age < or equal to 55) presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other vascular territory, and to evaluate the long-term outcome of young women with NACAD in comparison to those with atherosclerotic CAD over a 5-year follow-up.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All women aged 55 or younger having a coronary angiogram for acute coronary syndrome (ACS) will be approached prior to their procedure. A pregnancy test will be performed (standard for pre-menopausal women due to potential radiation exposure). If the cause of the heart attack is uncertain (eg no obvious infarct-related narrowing or occlusion), intravascular ultrasound or optimal coherence tomography will be performed within the context of the angiogram to better view the artery wall. A picture of the iliac and renal arteries will be accomplished by aortography (one dye shot down the aorta); in the case that the renal arteries are not well visualized, selective renal angiography will be performed (catheter at the entry to the renal artery). In the case of suspected non-atherosclerotic abnormalities, a head CT angiogram wil be performed. Referral to appropriate specialists for detected abnormality will occur. If symptoms continue, the subject will be followed by a cardiologist. A research coordinator will contact the subject at 1, 6 and 12 months and then annually to collect data on medications, hospitalization and symptoms.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Registry of Young Women With MI: Evaluating the Prevalence and Long-term Impact of Non-atherosclerotic CAD (PRYME)
    Study Start Date :
    Dec 1, 2011
    Actual Primary Completion Date :
    Jan 13, 2021
    Actual Study Completion Date :
    Jan 13, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the etiology of MI [5 years]

      To evaluate the etiology of myocardial infarction among young women (age < or equal to 55) based on angiographic and adjunctive imaging by core laboratory assessment

    2. Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI [5 years]

      Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI

    3. to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women [5 years]

      to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women aged 55 or younger with a troponin positive acute coronary syndrome (ST and non-ST elevation myocardial infarction or Acute Coronary Syndrome (ACS)) having a coronary angiogram

    • negative pregnancy test for women of child bearing age

    Exclusion Criteria:
    • Creatinine clearance <50

    • not willing to undergo an angiogram

    • troponin negative ACS

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vancouver General Hospital Vancouver British Columbia Canada

    Sponsors and Collaborators

    • Cardiology Research UBC
    • University of British Columbia

    Investigators

    • Principal Investigator: Jacqueline Saw, MD, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacqueline Saw, MD, Principal Investigator, Dr. Jackie Saw, Vancouver General Hospital
    ClinicalTrials.gov Identifier:
    NCT01479140
    Other Study ID Numbers:
    • H11-03186
    First Posted:
    Nov 24, 2011
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by Jacqueline Saw, MD, Principal Investigator, Dr. Jackie Saw, Vancouver General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 15, 2021