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Prevalence and Long-term Impact of Non-atherosclerotic CAD

Prospective Registry of Young Women With MI: Evaluating the Prevalence and Long-term Impact of Non-atherosclerotic CAD (PRYME)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01479140
Acronym
PRYME
Enrollment
160
Registered
2011-11-24
Start date
2011-12-31
Completion date
2021-01-13
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, dissection, coronary Fibromuscular Dysplasia, coronary ectasia, atherosclerotic Coronary Artery Disease, coronary vasculitis, coronary embolism, congenital coronary anomaly

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.

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.

Interventions

None listed

Sponsors

University of British Columbia
CollaboratorOTHER
Cardiology Research UBC
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the etiology of MI5 yearsTo evaluate the etiology of myocardial infarction among young women (age \< or equal to 55) based on angiographic and adjunctive imaging by core laboratory assessment
Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI5 yearsEvaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI
to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women5 yearsto screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026