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Intermountain INSPIRE Registry

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ClinicalTrials.gov Identifier: NCT02450006
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Tracking Information
First Submitted Date April 20, 2015
First Posted Date May 21, 2015
Last Update Posted Date August 10, 2022
Study Start Date April 2015
Estimated Primary Completion Date April 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2015)		 All-cause mortality [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intermountain INSPIRE Registry
Official Title INtermountain Healthcare Biological Samples Collection Project and Investigational REgistry for the On-going Study of Disease Origin, Progression and Treatment (Intermountain INSPIRE Registry)
Brief 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.
Detailed 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 Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 50 Years
Biospecimen Retention:   Samples With DNA
Description:

Examples of the biological samples that may be collected are as follows (but not limited to):

  • Blood/Plasma
  • Bone Marrow
  • Buccal smear (cheek)
  • Cartilage
  • Cerebrospinal fluid
  • Mucus
  • Saliva
  • Sputum
  • Stool
  • Sweat
  • Synovial fluid
  • Tears
  • Tissue samples (e.g. muscle, skin, nails, tumor, etc)
  • Urine
  • Seminal fluid
  • Genetic material extracted from any biological sample
  • Other biological samples as identified by the Principal Investigator or Co-Investigators and agreed by the patient.
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with any healthcare-related conditions who are seen at facilities affiliated with Intermountain Healthcare, including patients and their family members, the general population, including disease-free subjects.
Condition Condition
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Bartholomew CL, Muhlestein JB, Anderson JL, May HT, Knowlton KU, Bair TL, Le VT, Bailey BW, Horne BD. Association of periodic fasting lifestyles with survival and incident major adverse cardiovascular events in patients undergoing cardiac catheterization. Eur J Prev Cardiol. 2022 Jan 11;28(16):1774-1781. doi: 10.1093/eurjpc/zwaa050.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2015)		 50000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2050
Estimated Primary Completion Date April 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Joseph B Muhlestein, MD 801-507-4701 brent.muhlestein@imail.org
Contact: Patti Spencer 801-507-4778 patti.spencer@imail.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02450006
Other Study ID Numbers 1024811
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Intermountain Health Care, Inc.
Original Responsible Party Same as current
Current Study Sponsor Intermountain Health Care, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Intermountain Health Care, Inc.
Verification Date August 2022