Prevalence and Long-term Impact of Non-atherosclerotic CAD
PRYME
Prospective Registry of Young Women With MI: Evaluating the Prevalence and Long-term Impact of Non-atherosclerotic CAD (PRYME)
1 other identifier
observational
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2021
CompletedJanuary 15, 2021
January 1, 2021
9.1 years
November 22, 2011
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluate the etiology of MI
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
5 years
Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI
Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI
5 years
to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women
to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women
5 years
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- Creatinine clearance \<50
- not willing to undergo an angiogram
- troponin negative ACS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiology Research UBClead
- University of British Columbiacollaborator
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline Saw, MD
University of British Columbia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Dr. Jackie Saw
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 24, 2011
Study Start
December 1, 2011
Primary Completion
January 13, 2021
Study Completion
January 13, 2021
Last Updated
January 15, 2021
Record last verified: 2021-01