Prevalence and Long-term Impact of Non-atherosclerotic CAD (PRYME)

January 13, 2021 updated by: Jacqueline Saw, MD, Cardiology Research UBC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the etiology of MI
Time Frame: 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
5 years
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
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
Time Frame: 5 years
to screen for the prevalence of SCAD and coronary FMD as the predominant non-atherosclerotic cause for MI in young women
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiology Research UBC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacqueline Saw, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H11-03186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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