Cardiac Function and PreconditioningNCT06390358
Effects of Remote Cardiac Ischemic Preconditioning
A study testing Tefillin in people with Cardiac Function and Preconditioning, run by Jack Rubinstein at 1 site in United States.
Trial summary
A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function and Preconditioning
- What is being tested?
- Tefillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females over 18 years of age
Who cannot join
- Current medication use for medical condition or active medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
jack rubinstein, 517-388-6217, rubinsjk@ucmail.uc.edu
Sheryl Koch, PhD, 5132186723, kochse@ucmail.uc.edu
About this study
Official title: Acute and Chronic Effects of Tefillin Use on Remote Cardiac Ischemic Preconditioning
A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that "preconditioning" has powerful protective effects. Through the observation of Jewish men wearing tefillin the investigators have discovered a method of bringing preconditioning to patients at risk for heart attacks. This study will focus on women as the majority of people who wear tefillin (and have been studied) are men.
Read the detailed description
Remote ischemic preconditioning (RIPC) is a process via which short bursts of ischemia result in dramatic subsequent protection in remote organs from a prolonged ischemic injury such as myocardial infarction from reperfusion injury. The translation of RIPC stimuli to clinically relevant therapies has not been successful as almost all prior research on RIPC (animal and human) involved the full blockage of blood flow to an organ or extremity (in humans commonly with full inflation cycles of a blood pressure cuff). Our laboratory's key translational insight involved the Jewish tradition of donning tefillin (phylacteries) that is traditionally worn on an almost daily basis by Jewish orthodox men on the non-dominant arm in a non-obstructive manner (NOB).
My laboratory has made substantial progress by demonstrating that tefillin induced NOB induces an RIPC phenotype in healthy (mostly) men. The overarching hypothesis of this proposal is that full arm NOB via tefillin results in a preconditioning stimulus in women that is sufficient to induce an RIPC phenotype. The sole aim will test the hypothesis that full arm NOB (in healthy females) results in an inducible RIPC phenotype that increases over time as measured via clinically relevant variables derived from heart rate variability monitoring and inflammatory markers.
- Conditions
- Cardiac Function and Preconditioning
- Being tested
- Tefillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TefillinOther
Wrapping of arm
| Study group | Role | What they receive |
|---|---|---|
| Tefillin | Experimental | Wearing of tefillin in traditional manner Receives: Other: Tefillin |
| Capsaicin | Active comparator | Applying cream to non-dominant arm Receives: Other: Tefillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
HRV is determined by measuring the beat-to beat intervals.
Measured: 6 days
Secondary outcomes (1)
Inflammatory changes
Plasma will be analyzed for CCR2, CX3CR1, MCP-1 and VCAM1 and monocytes will be analyzed via migration and adhesion assays.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Function and PreconditioningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jack Rubinstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jack Rubinstein, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390358
- Sponsor's protocol ID
- 2023-0733
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Tefillin Use on Remote Cardiac Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT06390358
- Acronym / sponsor ID
- 2023-0733
- Conditions
- Cardiac Function and Preconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jack RubinsteinUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- 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.
A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that "preconditioning" has powerful protective effects. Through the observation of Jewish men wearing tefillin the investigators have discovered a method of bringing preconditioning to patients at risk for heart attacks. This study will focus on women as the majority of people who wear tefillin (and have been studied) are men.
Detailed description
Remote ischemic preconditioning (RIPC) is a process via which short bursts of ischemia result in dramatic subsequent protection in remote organs from a prolonged ischemic injury such as myocardial infarction from reperfusion injury. The translation of RIPC stimuli to clinically relevant therapies has not been successful as almost all prior research on RIPC (animal and human) involved the full blockage of blood flow to an organ or extremity (in humans commonly with full inflation cycles of a blood pressure cuff). Our laboratory's key translational insight involved the Jewish tradition of donning tefillin (phylacteries) that is traditionally worn on an almost daily basis by Jewish orthodox men on the non-dominant arm in a non-obstructive manner (NOB).
My laboratory has made substantial progress by demonstrating that tefillin induced NOB induces an RIPC phenotype in healthy (mostly) men. The overarching hypothesis of this proposal is that full arm NOB via tefillin results in a preconditioning stimulus in women that is sufficient to induce an RIPC phenotype. The sole aim will test the hypothesis that full arm NOB (in healthy females) results in an inducible RIPC phenotype that increases over time as measured via clinically relevant variables derived from heart rate variability monitoring and inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tefillin | Experimental | Other: TefillinWearing of tefillin in traditional manner |
| Capsaicin | Active comparator | Other: TefillinApplying cream to non-dominant arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females over 18 years of age
Key exclusion criteria (1 listed)
- Current medication use for medical condition or active medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TefillinWrapping of arm | Other | Capsaicin, Tefillin |
Primary outcome
Heart rate variability (HRV)
Time frame: 6 days
HRV is determined by measuring the beat-to beat intervals.
1 secondary outcome
Inflammatory changes
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tefillin in people with Cardiac Function and Preconditioning, run by Jack Rubinstein 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.