Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT05844566
Eligibility Criteria:
Inclusion criteria:
Sites:
* Manage ACS patients as defined by: Symptoms of myocardial ischemia with an unstable pattern, occurring at rest or with minimal exertion, within 72 hours of an unscheduled hospital admission due to presumed or proven obstructive coronary disease and at least one of the following:
* Elevated cardiac biomarkers
* Resting electrocardiographic changes consistent with ischemia or infarction, plus additional evidence of obstructive coronary disease from regional wall motion or perfusion abnormality, 70% or more epicardial coronary stenosis by angiography, or need for coronary revascularization procedure
* Mange post ACS follow up care of patients including risk factor control
* Ability to provide follow up information on patient care for a minimum of 16 weeks including blood tests
* Willing/ able to access and undertake training for the DSS
* Adequate internet connection at site and the ability to access the DSS
* No restrictions on use of LLTs (within national guidelines/ reimbursement)
* Ability to include all essential parameters and patient information for DSS input
Participants:
* Aged ≥18 to \< 80 years old
* Provide written informed consent
* Presenting to a study site with ACS as LLT naïve, monotherapy or combination therapy (defined as more than one LLT agent)
* Willing to take lipid lowering treatments for the secondary prevention of cardiovascular disease
* Attending the same study site (or same clinical team) for ACS follow up to ensure follow up data can be collected; or ensure that follow up data can be collected from other clinical institutions as part of the clinical pathway.
Exclusion criteria:
Sites:
* Unable to capture/ provide data on patients with ACS during admission and follow up
* Unable or unwilling to use lipid lowering treatments other than statins for ACS care
Participants:
* Unable to provide written informed consent
* LDL-C measurement \< 1.8 mmol/L at admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05844566
Study Brief:
Protocol Section:
NCT05844566