ConditionNCT02450006
Intermountain INSPIRE Registry
An observational study of Condition, run by Intermountain Health Care, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Condition
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2050
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center and Intermountain Clinics
Murray, Utah, 84143
Joseph B Muhlestein, MD, 801-507-4701, brent.muhlestein@imail.org
Patti Spencer, 801-507-4778, patti.spencer@imail.org
About this study
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)
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.
Read the 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:
- During a procedure from access lines inserted for the procedure, or
- When other ordered lab work is done, or
- 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.
- Conditions
- Condition
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2050 (estimated)
- Study completionApr 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450006
- Sponsor's protocol ID
- 1024811
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Horne BD, May HT, Muhlestein JB, Le VT, Bair TL, Knowlton KU, Anderson JL. Association of periodic fasting with lower severity of COVID-19 outcomes in the SARS-CoV-2 prevaccine era: an observational cohort from the INSPIRE registry. BMJ Nutr Prev Health. 2022 Jul 1;5(2):145-153. doi: 10.1136/bmjnph-2022-000462. eCollection 2022 Dec.
PubMed 36619318Bartholomew 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.
PubMed 33624026
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02450006
- Acronym / sponsor ID
- 1024811
- Conditions
- Condition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2050 (estimated)
- Study completion
- Apr 2050 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- During a procedure from access lines inserted for the procedure, or
- When other ordered lab work is done, or
- 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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 36619318Horne BD, May HT, Muhlestein JB, Le VT, Bair TL, Knowlton KU, Anderson JL. Association of periodic fasting with lower severity of COVID-19 outcomes in the SARS-CoV-2 prevaccine era: an observational cohort from the INSPIRE registry. BMJ Nutr Prev Health. 2022 Jul 1;5(2):145-153. doi: 10.1136/bmjnph-2022-000462. eCollection 2022 Dec.
- Derived from this study: PubMed 33624026Bartholomew 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Condition, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph B Muhlestein, MD (801-507-4701, brent.muhlestein@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02450006, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.