Effects of Remote Cardiac Ischemic Preconditioning

Jack Rubinstein

Status: Enrolling

Conditions: Cardiac Function and Preconditioning

Treatments: Other: Tefillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06390358

2023-0733

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females over 18 years of age

Exclusion criteria

• Current medication use for medical condition or active medical condition

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Tefillin

Experimental group

Description:

Wearing of tefillin in traditional manner

Treatment:

Other: Tefillin

Capsaicin

Active Comparator group

Description:

Applying cream to non-dominant arm

Treatment:

Other: Tefillin