Intermountain INSPIRE Registry

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Condition

Clinical Trial Details

NCT number	NCT02450006
Study type	Observational [Patient Registry]
Source	Intermountain Health Care, Inc.
Contact	Joseph B Muhlestein, MD
Phone	801-507-4701
Email	brent.muhlestein@imail.org
Status	Recruiting
Phase
Start date	April 2015
Completion date	April 2050

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.