NCT06390358

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

April 25, 2024

Last Update Submit

May 2, 2024

Conditions

Cardiac Function and Preconditioning

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability (HRV)

    HRV is determined by measuring the beat-to beat intervals.

    6 days

Secondary Outcomes (1)

  • Inflammatory changes

    6 days

Study Arms (2)

Tefillin

EXPERIMENTAL

Wearing of tefillin in traditional manner

Other: Tefillin

Capsaicin

ACTIVE COMPARATOR

Applying cream to non-dominant arm

Other: Tefillin

Interventions

TefillinOTHER

Wrapping of arm

CapsaicinTefillin

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females over 18 years of age

You may not qualify if:

  • Current medication use for medical condition or active medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

May 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)