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NCT03329612 Clinical Trial

Remote Ischemic Preconditioning in ACS Patients

Acute Coronary Syndrome Clinical Trial

Official title:
Remote Ischemic Preconditioning in ACS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03329612
Other study ID # RIPC in ACS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 26, 2016
Est. completion date December 30, 2018

Study information
Verified date December 2022
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor Exclusion Criteria: - Presenting with ST elevation myocardial infarction - Patients requiring circulatory support - Need for emergent percutaneous coronary intervention - Systemic hypotension (systolic blood pressure <90 mmHg) - Patients in cardiogenic shock defined by requiring inotropes or vasopressors - Patients currently on hemodialysis - Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm - Patients enrolled in other active cardiovascular investigational studies - Severe comorbidities with a life expectancy of less than 6 months - Pregnant or lactating women - Patients unable to provide consent - Patient taking the medication glibenclamide for treatment of diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Remote Ischemic Preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions.

Locations
Country Name City State
United States Henry Ford Hospital Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ischemic Burden Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers 48-72 hours
Secondary Clinical Outcomes Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission. 6 months
Secondary Renal Injury Assess the effects on post procedure renal injury 48-72 hours
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