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

This study is currently recruiting participants.
Verified March 2013 by Cardiology Research UBC
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Dr. Jacqueline Saw, Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT01479140
First received: November 22, 2011
Last updated: March 26, 2013
Last verified: March 2013

November 22, 2011
March 26, 2013
December 2011
June 2018   (final data collection date for primary outcome measure)
  • Evaluate the etiology of MI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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
  • Evaluate the relative distribution of normal coronary arteries, atherosclerotic, and non-atherosclerotic CAD in this population of young women with MI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluate 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 women [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women
Same as current
Complete list of historical versions of study NCT01479140 on ClinicalTrials.gov Archive Site
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Prospective Registry of Young Women With MI: Evaluating the 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)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Myocardial Infarction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2018
June 2018   (final data collection date for primary outcome measure)

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
Female
19 Years to 55 Years
No
Contact: Rebecca Fox 604-875-4065 rebecca.fox@ubc.ca
Canada
 
NCT01479140
H11-03186
No
Dr. Jacqueline Saw, Vancouver General Hospital
Cardiology Research UBC
University of British Columbia
Principal Investigator: Jacqueline Saw, MD University of British Columbia
Cardiology Research UBC
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP