Ignite Creation Date:
2024-05-06 @ 1:51 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04144725
Status:
RECRUITING
Last Update Posted:
2023-03-17
First Post:
2019-05-03
Brief Title:
Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
Official Title:
Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers Lightn Easy
Status:
RECRUITING
Status Verified Date:
2023-01
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:
ROCAMBOLE
Brief Summary:
A considerable proportion of patients with clinically suspected coronary artery disease CAD do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis In patients with suspected CAD we will assess the ability of cardiovascular biomarkers to identify patients with a angiographically normal epicardial coronary vessels b absence of significant epicardial coronary stenosis as assessed by coronary computed tomography angiography CCTA Patients will be stratified according to the presence or absence of dynamic changes of high sensitivity cardiac troponin T levels above the 99th percentile
Detailed Description:
This is an observational study of patients with suspected coronary artery disease referred to coronary computed tomography angiography CCTA The plan is to include 1000 patients prior to CCTA at two centers
Blood samples for biomarker measurement will be obtained prior to the procedures The diagnostic results of the imaging tests will be compared to the levels of circulating troponins Patient will be followed for a minimum of 12 months and the incidence of cardiovascular death all-cause mortality acute coronary syndromes revascularization heart failure stroke and cardiac arrhythmias requiring rehospitalization Symptoms of angina pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and symptoms of chronic heart failure according to the New York Heart Association classification of chronic heart failure will be recorded
Blood samples for biomarker measurement will be obtained prior to the procedures The diagnostic results of the imaging tests will be compared to the levels of circulating troponins Patient will be followed for a minimum of 12 months and the incidence of cardiovascular death all-cause mortality acute coronary syndromes revascularization heart failure stroke and cardiac arrhythmias requiring rehospitalization Symptoms of angina pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and symptoms of chronic heart failure according to the New York Heart Association classification of chronic heart failure will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None