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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01035294
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 21
2. ICD procedure
3. Ability to understand and speak English
4. Access to a telephone
Exclusion Criteria:
1. Inability or unwillingness to give informed consent
2. Signs of cognitive impairment (Blessed Orientation-Memory-Concentration (BOMS)scores \>10)
3. New York Heart Association (NYHA) functional class\>III, angina Canadian Cardiovascular Society(CCS) III and IV or clinically unstable
4. Awaiting coronary by-pass or heart transplantation
5. Co-morbid life threatening condition
6. Ongoing severe depression or psychosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01035294
Study Brief:
Protocol Section:
NCT01035294