Intermountain INSPIRE Registry

This is an observational, non-randomized, open, long-term project to collect a variety of
biological samples, in addition to usual or specialized care clinical information and
laboratory test results, from patients who present to Intermountain Healthcare-affiliated
facilities, with symptoms of any healthcare-related conditions, as well as from a general
population including disease-free subjects. The INSPIRE Registry will include all subjects
enrolled in the HHD registry (IRB # 1007406, approval date 01- 16-2009) and the cathlab
database registry (IRB # 1008366, approval date 10/04/2000), as of IRB approval date of this
INSPIRE amended protocol.

Since this is a registry database project, there are no investigational treatments, drugs or
procedures associated with participation. Information obtained from this registry project
will not have direct or immediate benefit for any of the participants.

Biological samples and subject information will be obtained during diagnostic procedures
and/or treatment that are generally part of usual or specialized care for the underlying
healthcare-related condition. Sample testing and registry data utilization for various
research projects can be initiated only after the appropriate approval is obtained from a
registry oversight/management committee, and when appropriate, the Institutional Review
Board.

After informed consent is obtained from the patient, the biological samples will be obtained
in one of the following ways:

1. During a procedure from access lines inserted for the procedure, or

2. When other ordered lab work is done, or

3. As a separate sample collection if no other lab work is planned. Biological sample
collection from the general population may be a separate blood draw and/or sample
collection. Participating patients may be asked to provide one or more collections of
biological samples. Biological samples may be used in current and future research tests
multiple times, or until the sample is consumed. In addition, participating subjects may
be asked to complete the IRBreviewed questionnaires.

Inclusion Criteria:

- Males or females of any age, any ethnicity, diagnosed with any healthcare-related
conditions, presenting to an Intermountain Healthcare-affiliated facility or males or
females of any age, any ethnicity, with or without any healthcare-related conditions,
including disease-free subjects, from a general population that may include unaffected
family members

- Patient or patient's representative has the ability to understand and sign a written
informed consent form, which must be obtained prior to initiation of any study
procedures, using a form that is approved by the applicable IRB.

Exclusion Criteria:

- Inability or refusal of the patient and/or the patient's legally-acceptable
representative to provide informed consent for any reason.

- Other conditions that in the opinion of the Principal Investigator or
Co-Investigator(s) may increase risk to the subject and/or compromise the quality of
the registry project.