Preconditioning with Tefillin for Heart Disease

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jack Rubinstein

Must not be taking: Any medications

Disqualifiers: Active medical condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications to participate in this trial, as it excludes those who are currently using medication for any medical condition.

What evidence supports the effectiveness of the treatment Tefillin for heart disease?

Research on ischemic preconditioning, a process where brief episodes of reduced blood flow protect the heart from future damage, suggests that similar protective mechanisms could be beneficial in heart disease. While Tefillin is not directly studied, the concept of preconditioning has shown promise in reducing heart damage in various studies. ^{1 2 3 4 5}

Is preconditioning with Tefillin safe for humans?

The research on ischemic preconditioning, which is a similar concept, suggests it is generally safe in humans, especially in the context of heart procedures. However, more studies are needed to fully understand its safety and effectiveness in different conditions. ^{1 4 6 7 8}

How does the treatment Tefillin differ from other treatments for heart disease?

Tefillin is unique because it involves the nonocclusive wrapping of the arm, which may trigger a protective effect similar to remote ischemic preconditioning (RIPC). This method is different from traditional drug treatments as it uses a physical approach to potentially improve heart health by enhancing blood flow and reducing inflammation. ^{2 9 10 11 12}

Eligibility Criteria

This clinical trial is for women over the age of 18 who are not currently taking medication for any medical condition and do not have an active medical condition. It's designed to explore a potential heart protection method observed in Jewish men wearing tefillin.

Inclusion Criteria

I am a woman older than 18.

Exclusion Criteria

I am currently taking medication for a health condition.

Active medical condition

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear tefillin in the traditional manner or apply capsaicin cream to the non-dominant arm

6 days

Daily visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Tefillin

Trial Overview The study investigates whether using tefillin, which may induce 'preconditioning', can protect against heart damage during a heart attack. This concept comes from animal studies suggesting preconditioning reduces reperfusion injury when blood flow returns after being blocked.

Participant Groups

Group I: Tefillin Experimental Treatment 1 Intervention

Wearing of tefillin in traditional manner

Group II: Capsaicin Active Control 1 Intervention

Applying cream to non-dominant arm

Who Is Running the Clinical Trial?

Jack Rubinstein

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

Ischemic preconditioning and postconditioning are effective strategies to protect the heart from damage caused by reperfusion injury after a heart attack, enhancing the heart's ability to withstand subsequent ischemic events.

However, the effectiveness of these cardioprotective strategies can be significantly influenced by comorbid conditions like diabetes and aging, which alter the heart's response to ischemia/reperfusion injury, highlighting the need for more targeted research in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of cardiovascular risk factors with myocardial ischemia/reperfusion injury, preconditioning, and postconditioning. Ferdinandy, P., Schulz, R., Baxter, GF.[2022]

Ischemic preconditioning significantly reduces heart damage during prolonged ischemia-reperfusion by activating protective molecular pathways, including protein kinase C and mitochondrial K(+)ATP channels, which help improve heart function and reduce infarct size.

The IONA trial demonstrated that chronic use of nicorandil, a drug that mimics the effects of ischemic preconditioning, can improve cardiovascular outcomes in patients with coronary artery disease, highlighting the potential for pharmacological approaches to enhance heart protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How to use the paradigm of ischemic preconditioning to protect the heart?]. Argaud, L., Ovize, M.[2007]

Brief episodes of nonlethal myocardial ischemia can protect the heart by making it more resistant to future, more severe ischemic events, as shown by reduced infarct size in preconditioned hearts compared to controls.

Research is actively exploring the cellular mechanisms behind this protective effect, the broader implications of ischemic preconditioning beyond just infarct size, and its potential efficacy in clinical settings and various disease models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning: exploring the paradox. Przyklenk, K., Kloner, RA.[2019]

In a study of 10 patients with variant angina, transient ischemic episodes were found to significantly protect against complex ventricular arrhythmias (CVAs) during subsequent ischemic events, indicating a potential therapeutic benefit of ischemic preconditioning.

The protective effect against CVAs was not linked to a decrease in the severity or duration of ischemia, suggesting that the mechanism of protection is a direct result of preconditioning rather than simply a byproduct of reduced ischemic stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconditioning by transient myocardial ischemia confers protection against ischemia-induced ventricular arrhythmias in variant angina. Pasceri, V., Lanza, GA., Patti, G., et al.[2019]

Ischemic preconditioning, which involves brief episodes of controlled ischemia, has been shown to protect the heart from more severe ischemic injury, suggesting that the heart has natural adaptive mechanisms to resist damage.

Research is ongoing to explore how these protective mechanisms can be induced in humans, with early studies indicating that preconditioning agents may improve heart protection during acute coronary syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angina: who needs it? Cardioprotection in the preconditioning era. Dana, A., Yellon, DM.[2019]

Ischemic preconditioning (IPC) significantly improved heart function recovery after ischemia/reperfusion in isolated rat hearts, showing a continuous trend of recovery in myocardial function.

Pharmacological preconditioning with omeprazole also provided protective effects, particularly in systolic left ventricular pressure, but was less effective than IPC; however, it offers a viable alternative in clinical situations where IPC is not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ischemia and omeprazole preconditioning on functional recovery of isolated rat heart. Jeremic, N., Petkovic, A., Srejovic, I., et al.[2018]

Ischemic preconditioning (IP) significantly reduced intestinal injury caused by ischemia-reperfusion in a rat model, showing a lower histologic injury score compared to the IR group (2.00 vs 3.60).

IP also decreased harmful markers in intestinal tissue, such as malondialdehyde, myeloperoxidase, and TNF-α levels, while reducing the expression of adhesion molecules (ICAM-1 and VCAM-1) and inhibiting NF-κB activity, suggesting a protective mechanism against inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning ameliorates intestinal injury induced by ischemia-reperfusion in rats. Ji, YY., Wang, ZD., Wang, SF., et al.[2022]

Ischemic preconditioning has shown promise in protecting the heart from damage during ischemic events, with evidence suggesting that the human myocardium can be preconditioned similarly to animal models, involving mechanisms like adenosine and protein kinase C.

Clinical studies indicate that preconditioning may improve outcomes in patients undergoing cardiac procedures, such as coronary artery bypass grafts, by reducing ATP depletion during ischemic episodes, although further research is needed to fully understand the mechanisms and develop safe pharmacological agents for preconditioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconditioning the human myocardium: recent advances and aspirations for the development of a new means of cardioprotection in clinical practice. Jenkins, DP., Steare, SE., Yellon, DM.[2020]

Chronic use of tefillin among Orthodox Jewish men is linked to improved vascular function and reduced inflammation, suggesting a remote ischemic preconditioning-like effect that may contribute to lower cardiovascular mortality.

Acute use of tefillin enhances artery diameter and blood flow in both tefillin users and non-users, indicating immediate benefits to vascular reactivity, although it does not significantly change inflammatory markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tefillin use induces remote ischemic preconditioning pathways in healthy men. Owens, AP., Robbins, N., Saum, K., et al.[2020]

The study found that non-obstructive banding (NOB) through the use of tefillin can induce a remote ischemic preconditioning (RIPC) response, which may help protect the heart from damage during ischemic events.

In a trial with 30 healthy subjects, NOB was associated with significant changes in heart rate variability (HRV) markers, suggesting that this method could be a potential clinical approach to reduce the risks associated with ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tefillin use induces preconditioning associated changes in heart rate variability. Koch, SE., Martin, E., Verma, A., et al.[2023]

Preconditioning the heart through brief periods of ischemia has been shown to significantly reduce heart tissue damage (infarct size) and may be beneficial in patients with coronary artery disease, as evidenced by improved outcomes in those experiencing angina before a heart attack.

Certain drugs, like adenosine and potassium channel openers, have been identified as potential mediators of this preconditioning effect, suggesting they could be used to protect heart tissue during procedures like coronary angioplasty, although more research is needed before they can be widely applied in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of ischemic preconditioning. Schwarz, ER., Reffelmann, T., Kloner, RA.[2019]

Ischaemic preconditioning helps protect the heart from damage during procedures like percutaneous transluminal coronary angioplasty (PTCA) by reducing the severity of myocardial ischaemia during repeated balloon inflations, indicating a protective mechanism of the heart.

Several drugs, such as adenosine and nitroglycerin, can mimic the effects of preconditioning, suggesting that developing these preconditioning-mimetic drugs could enhance heart tolerance to angina and reduce the risk of serious heart issues like sudden cardiac death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischaemic preconditioning and outcomes after angioplasty: effects of drug therapy. Kato, T., Yoshimoto, N.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interaction of cardiovascular risk factors with myocardial ischemia/reperfusion injury, preconditioning, and postconditioning. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[How to use the paradigm of ischemic preconditioning to protect the heart?]. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning: exploring the paradox. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Preconditioning by transient myocardial ischemia confers protection against ischemia-induced ventricular arrhythmias in variant angina. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Angina: who needs it? Cardioprotection in the preconditioning era. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

Effects of ischemia and omeprazole preconditioning on functional recovery of isolated rat heart. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning ameliorates intestinal injury induced by ischemia-reperfusion in rats. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Preconditioning the human myocardium: recent advances and aspirations for the development of a new means of cardioprotection in clinical practice. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Tefillin use induces remote ischemic preconditioning pathways in healthy men. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Tefillin use induces preconditioning associated changes in heart rate variability. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical effects of ischemic preconditioning. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Ischaemic preconditioning and outcomes after angioplasty: effects of drug therapy. [2018]