Condition Clinical Trial
INtermountain Healthcare Biological Samples Collection Project and Investigational REgistry for the On-going Study of Disease Origin, Progression and Treatment (Intermountain INSPIRE Registry)
|Study type||Observational [Patient Registry]|
|Source||Intermountain Health Care, Inc.|
|Contact||Joseph B Muhlestein, MD|
|Start date||April 2015|
|Completion date||April 2050|
To collect biological samples, clinical information and laboratory data from patients diagnosed with any healthcare-related conditions who are seen at facilities affiliated with Intermountain Healthcare, including patients and their family members, and to collect the same information and samples from a general population including disease-free subjects.
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.
Observational Model: Ecologic or Community, Time Perspective: Prospective