Trial record 4 of 4 for:    Fibromuscular Dysplasia

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. (see Contacts and Locations)
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
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Young Women With MI: Evaluating the Prevalence and Long-term Impact of Non-atherosclerotic CAD (PRYME)

Resource links provided by NLM:


Further study details as provided by Cardiology Research UBC:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479140

Contacts
Contact: Rebecca Fox 604-875-4065 rebecca.fox@ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Rebecca Fox    604-875-4065    rebecca.fox@ubc.ca   
Principal Investigator: Jacqueline Saw, MD         
Sub-Investigator: Jaap Hamburger, MD         
Sub-Investigator: David Wood, MD         
Sub-Investigator: John G.B. Mancini, MD         
Sponsors and Collaborators
Cardiology Research UBC
University of British Columbia
Investigators
Principal Investigator: Jacqueline Saw, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Jacqueline Saw, Principal Investigator, Dr. Jackie Saw, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT01479140     History of Changes
Other Study ID Numbers: H11-03186
Study First Received: November 22, 2011
Last Updated: March 26, 2013
Health Authority: Canada: University of British Columbia Clinical Research Ethics Board

Keywords provided by Cardiology Research UBC:
myocardial infarction
dissection
coronary Fibromuscular Dysplasia
coronary ectasia
atherosclerotic Coronary Artery Disease
coronary vasculitis
coronary embolism
congenital coronary anomaly

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014