search
Back to results

Impact of Ischemic Post-conditioning

Primary Purpose

ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Primary per-cutaneous coronary intervention
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset < 12 hours & meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):

    • Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL)
    • Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves
    • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
  2. Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.

Exclusion Criteria:

  1. Patients with transient ST segment elevation in the surface electrocardiography.
  2. Patients presenting within > 12 hours from the onset of maximal symptoms.
  3. Patients with evidence of pre-infarction angina.
  4. Patients with evidence of collateral blood flow to the infarct region on their angiogram.
  5. Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
  6. Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Postconditioning in primary percutaneous coronary intervention

    Primary percutaneous coronary intervention

    Arm Description

    Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion & re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon

    Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning

    Outcomes

    Primary Outcome Measures

    Left ventricular remodeling
    percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2019
    Last Updated
    September 4, 2019
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04068116
    Brief Title
    Impact of Ischemic Post-conditioning
    Official Title
    Impact of Ischemic Post-conditioning During Primary Percutaneous Coronary Intervention on Left Ventricular Remodeling and Global Systolic Function in Patients Presenting With ST-Elevation Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2019 (Anticipated)
    Primary Completion Date
    October 15, 2020 (Anticipated)
    Study Completion Date
    October 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study will investigate & compare the left ventricular remodeling & systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.
    Detailed Description
    Among re-perfusion strategies for the management of ST-elevation myocardial infarction , primary per-cutaneous coronary intervention is the preferred one within 120 minutes from the first medical contact.However , restoration of the coronary blood flow can paradoxically reduce the beneficial effects of myocardial re-perfusion , a phenomenon known as myocardial re-perfusion injury.Ischemic post-conditioning has been described as a measure for myocardial salvage , performed by making cycles of briefly interrupted perfusion during the early moments of coronary re-flow.Post-conditioning may be performed immediately after the early re-flow by creating cycles of interrupted inflation & deflation of the angioplasty balloon in patients undergoing primary per-cutaneous coronary intervention.In this study investigators aim to compare the left ventricular remodeling and global systolic function immediately & 6 months after re-perfusion between two groups of 100 patients presenting with acute ST-elevation myocardial infarction, using ischemic post-conditioning in one group of patients undergoing primary per-cutaneous coronary intervention (n=50 patients) by making 4 cycles of repeated occlusion & re-perfusion 30-second each by inflation/deflation of an appropriately sized per-cutaneous trans-luminal coronary angioplasty balloon.The other group will be investigated after re-perfusion by primary per-cutaneous coronary intervention without ischemic post-conditioning (n=50 patients)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction, Ischemic Reperfusion Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Postconditioning in primary percutaneous coronary intervention
    Arm Type
    Experimental
    Arm Description
    Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion & re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon
    Arm Title
    Primary percutaneous coronary intervention
    Arm Type
    Active Comparator
    Arm Description
    Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning
    Intervention Type
    Procedure
    Intervention Name(s)
    Primary per-cutaneous coronary intervention
    Intervention Description
    Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention including balloon angioplasty & coronary stent deployment as needed +/- post-conditioning (for post-conditioning arm) making 4 cycles of repeated occlusion & reperfusion 30-second each by inflation/deflation of an appropriately sized PTCA (percutaneous transluminal coronary angioplasty) balloon
    Primary Outcome Measure Information:
    Title
    Left ventricular remodeling
    Description
    percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)
    Time Frame
    Immediate-6 months
    Other Pre-specified Outcome Measures:
    Title
    Left ventricular Ejection Fraction
    Description
    is a simple measure of global systolic function that pervades the risk evaluation and management of many cardiovascular diseases
    Time Frame
    Immediate-6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset < 12 hours & meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019): Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL) Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology. Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy. Exclusion Criteria: Patients with transient ST segment elevation in the surface electrocardiography. Patients presenting within > 12 hours from the onset of maximal symptoms. Patients with evidence of pre-infarction angina. Patients with evidence of collateral blood flow to the infarct region on their angiogram. Patients with history of old myocardial infarction causing chronic impairment of LV systolic function. Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction

    12. IPD Sharing Statement

    Learn more about this trial

    Impact of Ischemic Post-conditioning

    We'll reach out to this number within 24 hrs