Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382402
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-19
Brief Title:
A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Randomized Control Trial of Outcomes Comparing a Coronary Computed Tomography Angiography CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 Non-ST-elevation MI
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography CCTA vs conservative treatment in type 2 NSTEMI The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI
Detailed Description:
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography CCTA vs conservative treatment in type 2 NSTEMI The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI Patients are randomized into 2 groups Group 1 undergoes coronary 64-detector row computed tomography angiography CCTA and Group 2 receives conservative management and treatment for underlying conditions The investigators will evaluate cross-sectional and time-varying clinical laboratory and imaging characteristics in association with clinical events The exclusion criteria are an absence of information for follow-up of clinical events and patients who have absolute and relative contraindications for CCTA Absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast inability to cooperate with scan protocols hemodynamic instability decompensated heart failure acute myocardial infarction and renal impairment with GFR 30 Relative contraindications include pregnancy inability to tolerate heart rate-slowing medications or nitroglycerin recent phosphodiesterase inhibitor use severe aortic stenosis bronchospastic disease and patients weight and height
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None