Effects of Remote Cardiac Ischemic Preconditioning

NCT ID: NCT06390358

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-01

Brief 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 "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.

Conditions

Cardiac Function and Preconditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tefillin

Wearing of tefillin in traditional manner

Group Type: EXPERIMENTAL

Tefillin

Intervention Type: OTHER

Wrapping of arm

Capsaicin

Applying cream to non-dominant arm

Group Type: ACTIVE_COMPARATOR

Tefillin

Intervention Type: OTHER

Wrapping of arm

Interventions

Tefillin

Wrapping of arm

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Females over 18 years of age

Exclusion Criteria

• Current medication use for medical condition or active medical condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jack Rubinstein

OTHER

Sponsor Role: lead

Responsible Party

Jack Rubinstein

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

jack rubinstein

Role: primary

rubinsjk@ucmail.uc.edu

517-388-6217

Sheryl Koch, PhD

Role: backup

kochse@ucmail.uc.edu

5132186723

Other Identifiers

2023-0733

Identifier Type: -

Identifier Source: org_study_id