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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT05607992
Eligibility Criteria:
Inclusion Criteria:
* (A) ACS ≥ four weeks to six months before assessment (MI type 1 STEMI/NSTEMI and UA)
* (B) Age 18-80 years
* (C) Symptoms of PTSD and/or cardiac anxiety that leads to distress and/or interferes with daily life (PCL5; ≥ 10, CAQ: ≥20)
* (D) On standard of care medical treatment for the cardiac condition according to Swedish cardiovascular guidelines
* (E) Ability to read and write in Swedish.
Exclusion Criteria:
* (F) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
* (G) Significant valvular disease
* (H) Planned coronary artery bypass surgery or percutaneous interventions
* (I) Any medical restriction to physical exercise
* (J) Severe uncontrolled medical illness i.e., advanced cancer
* (K) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
* (L) Severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities
* (M) Alcohol dependency
* (N) Ongoing psychological treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05607992
Study Brief:
Protocol Section:
NCT05607992