Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390358
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-25
Brief Title:
Effects of Remote Cardiac Ischemic Preconditioning
Sponsor:
Jack Rubinstein
Organization:
University of Cincinnati
Study Overview
Official Title:
Acute and Chronic Effects of Tefillin Use on Remote Cardiac Ischemic Preconditioning
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 laboratorys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None