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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01736566
Eligibility Criteria:
Note for Age Eligibility:
* Cardiology patients 18 Years to 90 Years OR
* Primary Care Patients 40 Years to 65 Years (Adult, Senior)
Inclusion Criteria:
Primary Care
* Generally healthy (as defined by the primary care provider) adult patients at Brigham and Women's Hospital ages 40-65. All patients must be fluent in English.
Cardiology
* Patients in the Partners Healthcare System who are 18 years or older with a diagnosis of hypertrophic cardiomyopathy (HCM) or dilated cardiomyopathy (DCM) and a family history of HCM or DCM who previously had or who are candidates for targeted HCM or DCM genetic testing through routine clinical practice within Partners. All patients must be fluent in English.
Exclusion Criteria:
Primary Care
* Patients who do not meet the above criteria. Patients with cardiac disease or a progressive debilitating illness. Patients who are pregnant or patients whose spouses/significant others are pregnant. Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score \> 11 administered at the baseline study visit.)
Cardiology
* Patients who do not meet the above criteria. Patients with a progressive debilitating illness. Patients who are pregnant or patients whose spouses/significant others are pregnant. Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score \> 11 administered at the baseline study visit.)
Extension Phase - Additional Inclusion Criteria
Part 1:
* Above inclusion and exclusion criteria PLUS:
* Inclusion: Self-identify as African or African American.
Part 2:
Inclusion Criteria
* MedSeq participants determined to have a monogenic finding
Exclusion Criteria
* Participants not previously enrolled in MedSeq Project
* Participants not identified to have a monogenic finding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01736566
Study Brief:
Protocol Section:
NCT01736566