NCT01479140

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

9.1 years

First QC Date

November 22, 2011

Last Update Submit

January 13, 2021

Conditions

Keywords

myocardial infarctiondissectioncoronary Fibromuscular Dysplasiacoronary ectasiaatherosclerotic Coronary Artery Diseasecoronary vasculitiscoronary embolismcongenital coronary anomaly

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

Age19 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jacqueline Saw, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations