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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT06186102
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 65 years
* Chronic ischemic heart disease (previous revascularization or myocardial infarction)
* Left ventricular ejection fraction of \> 40%
And at least two of the following risk factors:
* Type 2 diabetes,
* Obesity (BMI ≥ 30 kg/m2),
* Hypertension,
* Previous LVEF \< 40%,
* Left atrial volume index ≥ 30 mL/m2
* Left ventricular wall thickness ≥ 1.1 cm.
Exclusion Criteria:
* Unstable coronary syndrome
* Significant and severe cardiac valve disease
* Severe peripheral artery disease
* Permanent atrial fibrillation
* Pacemaker treatment
* Chronic kidney disease with eGFR \<45 ml/min/1,73m2
* Severe comorbidity as judged by the investigator (such as severe pulmonary, neurological, or musculoskeletal disease)
* Inability to give informed consent.
Exclusion criteria for MRI:
* Some metallic implants
* Claustrophobia
Exclusion criteria for muscle biopsy:
* Treatment with either two antiplatelet drugs (aspirin and ADP-receptor antagonists)
* Anticoagulants (warfarin, NOACs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
90 Years
Study:
NCT06186102
Study Brief:
Protocol Section:
NCT06186102