Clinical Trials

Inclusion Criteria:

• Patients/decedents must have cardiovascular disease that is clinically, radiologically or pathologically identified.

• Prospectively identified patient is willing to undergo session(s) with a genetic counselor (GC) to discuss results, should they be relevant to their medical care.

• Prospectively identified patients must understand and provide written informed consent and HIPAA authorization prior to enrollment in the study.

  • If the patient or family member who is being enrolled is not English speaking, the approved institutional procedures for interfacing with non-English speaking prospective subjects who are not specifically targeted for the project. This includes:

    • Having an independent medical interpreter provide an oral explanation (in person or by phone) of the entire content of the English version of the approved consent document to the prospective subject or the legally-recognized next-of-kin.

    • Using the IRB's written Short Form / Authorization to Use and Disclose Protected Health Information form, stating that the elements of informed consent have been presented orally. A short form that has be translated into a language understandable to the subject will be provided.

    • Having a witness, who might be the interpreter, to the oral presentation who is conversant in both the English language and the language of the prospective subject.

    • Making certain that the prospective subject or his/her representative has signed the translated Short Form/Authorization to Use and Disclose Protected Health Information form.

    • Making certain that the witness has signed both the translated Short Form and a copy of the English consent document.

    • Making certain that the person obtaining consent has signed a copy of the English consent document.

    • Making certain a copy of the translated Short Form and a copy of the English consent document are given to the prospective subject or the prospective subject's representative.

Exclusion Criteria:

• Patients with psychiatric illness or social situations that would limit compliance with the study requirements or the ability to provide, willingly, written informed consent.

• Women who are pregnant at the time of surgery.