|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02959099 |
|
Date of registration:
|
04/11/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Incident COronary EveNts Identified by Computed Tomography
ICONIC |
|
Scientific title:
|
Incident COronary EveNts Identified by Computed Tomography |
|
Date of first enrolment:
|
July 20, 2012 |
|
Target sample size:
|
476 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02959099 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Austria
|
Canada
|
Germany
|
Italy
|
Korea, Republic of
|
Netherlands
|
Portugal
|
United States
|
|
Contacts
|
|
Name:
|
Leslee J Shaw, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Weill Cornell Medicine |
| | |
|
Key inclusion & exclusion criteria
|
Cases:
Inclusion criteria:
- Age =18 years.
- Adjudicated STEMI / NSTEMI / UA / Unclassified MI (except for type 4a, 4b, or 5 MI)
- Baseline CCTA.
Exclusion criteria:
- Myocardial infarction not meeting the definition of ACS with missing cardiac
biomarkers.
- Prior history of CAD (revascularization or MI).
- Prior revascularization (PCI or CABG).
- ACS in a previously revascularized segment.
- Type 4a, 4b, or 5 MI.
Controls
Inclusion criteria:
- Age =18 years.
- Propensity score matched.
Exclusion criteria:
- Prior history of CAD (revascularization or MI).
- Death as an outcome.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Atherosclerosis
|
|
Primary Outcome(s)
|
|
ACS
[Time Frame: within 5 years]
|
|
Secondary Outcome(s)
|
|
STEMI and NSTEMI
[Time Frame: within 5 years]
|
|
Secondary ID(s)
|
|
1310014469
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|