Impact of Ischemic Post-conditioning

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04068116

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction Ventricular Remodeling Ventricular Dysfunction Ischemic Reperfusion Injury	Procedure: Primary per-cutaneous coronary intervention	N/A

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 15, 2019

Anticipated Primary Completion Date :

Oct 15, 2020

Anticipated Study Completion Date :

Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Postconditioning in primary percutaneous coronary intervention 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	Procedure: Primary per-cutaneous coronary intervention 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
Active Comparator: Primary percutaneous coronary intervention Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning	Procedure: Primary per-cutaneous coronary intervention 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

Arm

Intervention/Treatment

Experimental: Postconditioning in primary percutaneous coronary intervention

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

Procedure: Primary per-cutaneous coronary intervention

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

Active Comparator: Primary percutaneous coronary intervention

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

Procedure: Primary per-cutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

Left ventricular remodeling [Immediate-6 months]
percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)

Other Outcome Measures

Left ventricular Ejection Fraction [Immediate-6 months]
is a simple measure of global systolic function that pervades the risk evaluation and management of many cardiovascular diseases

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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