Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01479140
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2011-11-22
Brief Title:
Prevalence and Long-term Impact of Non-atherosclerotic CAD
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Prospective Registry of Young Women With MI Evaluating the Prevalence and Long-term Impact of Non-atherosclerotic CAD PRYME
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRYME
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None