Ischemic Conditioning in STEMI Patients (EDICT)

October 27, 2024 updated by: Nathan Shapiro, Beth Israel Deaconess Medical Center

The Effect of Remote Ischemic Conditioning on the Metabolomic Profile of NSTEMI Patients

The purposes of the study are to 1) study alterations in the metabolomic profile of patients exposed to post-ischemic conditions and 2) study alterations in myocardial infarction size of patients exposed to post-ischemic conditioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myocardial infarction is a common, morbid and mortal disease. This study will examine both the clinical effects of the treatment as well as the molecular mechanism. Evaluating patients in the emergency department (ED) is more than a daily occurrence for every practicing emergency physician in the country. Every year there are approximately 4.5 million visits to the ED for chest pain and over 1.5 million hospitalizations for acute coronary syndrome (ACS).2 Despite its prevalence, ACS is a difficult diagnosis to evaluate and manage; it involves taking a thorough history and performing a physical as well as performing an electrocardiogram (ECG) and biomarker analysis. The pathogenesis of unstable angina and non-ST segment elevation myocardial infarctions (NSTEMI) involves occlusive narrowing of a coronary artery, usually from an atherosclerotic plaque. The downstream effect of which is inadequate oxygen delivery to the myocardium, resulting in cell death.

Ischemic conditioning is the protective mechanism by which brief episodes of ischemia protect the heart from ischemia-reperfusion injury. There are two types of ischemic conditioning commonly referred to in the literature: pre-conditioning and post-conditioning. In the example of pre-operative coronary artery bypass graft (CABG) patients who may experience a degree of ischemia peri-operatively, ischemic conditioning can be performed before the surgery to prevent or limit myocardial injury. In the example of a patient with an ongoing STEMI who is going to the interventional cardiology suite for a percutaneous intervention, post-ischemic conditioning therapy may prevent or limit myocardial injury. A "remote" qualifier specifies that the therapy is implemented by inducing ischemia at a location that is not the heart itself.

The investigators propose to leverage the novel technique of metabolomics to better study the mechanisms behind ischemic post-conditioning. This study will pair clinical human data with molecular data. It is a novel theoretical concept in the field and the investigators believe that this methodology will be the basis for future research.

The investigators will utilize metabolomics as a tool to gain mechanistic insight into the potential mechanisms of action behind ischemic conditioning. Metabolomics is a burgeoning field of molecular biology that studies the metabolome, the catalogue of material and product of every biochemical reactions in the body occurring at that point in time. As such, the metabolome is ever changing and can reflect what the body is doing, not doing or responding to, and if so, by how much for each of the over 2,500 known human metabolites. Because there is such a large amount of data available by this technique, proper analysis requires the use of proprietary statistical software that can account for the effect of random chance in the data.

The particular innovation to this methodology compared to other studies to date is that we will pair biological as well as clinical data for analysis. This means that even if the investigators cannot find a difference in troponin levels between the treatment and control groups, the investigators will have some data on where to investigate next and be able to detect the biological response that remote post-ischemic conditioning induces. If this particular therapy does not develop any further, at least the investigators will know what appropriate mechanisms are at work and perhaps some of those could be targeted by pharmaceuticals in the future. Finally, if the investigators detect no differences at all, this will serve as an argument against the potential of ischemic post-conditioning in the NSTEMI population.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient 18 ≥ years old in the BIDMC ED
  • Clinical suspicion of myocardial infarction
  • ECG without pathognomonic ST-segment elevation
  • At least one positive troponin-T (>0.10)

Exclusion Criteria:

  • Inability to consent to enrollment
  • Concurrent diagnosis of an emergent condition that may be antecedent to the NSTEMI
  • Presentation to the ED greater than 24 hours after onset of NSTEMI symptoms
  • Patients with a history of mastectomy or upper extremity arteriovenous fistula.
  • Patients with active medication administration in both arms will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Remote post-ischemic conditioning
Procedure: Remote post-ischemic conditioning

A manual sphygmomanometer will be inflated over the brachial artery of the participants' arm that does not have an intravenous catheter actively infusing medications. If both arms are in use, then the participant's non-dominant arm will be used.

  • The sphygmomanometer will be inflated to a pressure at least 20 mmHg greater than the participants' last recorded systolic blood pressure.
  • The sphygmomanometer will be inflated for 5 minutes then rapidly deflated for 5 minutes, thereby concluding one iteration.
  • Five (5) total iterations constitute the treatment.
  • The left arm will be preferentially used instead of the right arm, unless the left arm is receiving medication administration.
No Intervention: Control
Standard medical care by the primary treatment team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Metabolomic Profile
Time Frame: Time: 0 minutes (baseline), 60 minutes, 2 hours, 3 hours, 24 hours, and 72 hrs.
The change in metabolic profiles as compared to a subject's baseline readout will be analyzed using both, an "untargeted" and a "targeted" approach. A comparison of the these changes will be made between the interventional and control groups.
Time: 0 minutes (baseline), 60 minutes, 2 hours, 3 hours, 24 hours, and 72 hrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Nathan Shapiro, MD MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2012

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

March 27, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may make the de-identified data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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