ST Segment Resolution After Primary Percutaneous Coronary Intervention.

• Conditions: ST Segment Elevation Myocardial Infarction
• Interventions: Procedure: Percutaneous primary coronary intervention

• Registration Number: NCT03895983
• Lead Sponsor: Assiut University

Brief Summary

To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE

Detailed Description

The idea of an occluding thrombus and its dissolution had been stated since the 1950s.1 Thrombus is present in the infarct-related artery in 88% of patients undergoing coronary artery angiography within the first 4 h of acute myocardial infarction (AMI).

The finding of ST segment elevation in a patient presenting with chest pain allows rapid identification of those who benefit from emergency reperfusion.

Primary percutaneous coronary intervention (PPCI) is now the preferred strategy for emergency reperfusion in patients presenting with ST elevation myocardial infarction (STEMI).

Thrombus aspiration (TA) might be an effective procedure for reducing distal embolization and improving microvascular perfusion in ST-segment elevation myocardial infarction (STEMI), especially in patients with high thrombus burden.

Despite the class III recommendation for routine Thrombus Aspiration use before balloon angioplasty or stenting. manual Thrombus Aspiration might still remain a useful strategy for the interventional cardiologist when treating selected patients with significant thrombus burden during PPCI.

Thrombus grading is classified as:

Grade 0: No angiographic characteristics of thrombus are present. Grade 1: Possible thrombus is present with a such characteristics as: Reduced contrast density, haziness, irregular lesion contour Or smooth convex meniscus at the site of total occlusion Suggestive but not diagnostic of the thrombus.

Grade 2: There is a definite thrombus with greatest dimension \<1/2 the vessel diameter.

Grade 3: There is a definite thrombus but with greatest linear dimension\>1/2 but \<2 vessel dimension.

Grade 4: There is a definite thrombus but with greatest linear dimension \>2 vessel dimension.

Grade 5: There is a total occlusion (unable to assess thrombus burden due to total vessel occlusion.

The analysis of ST-segment resolution on the electrocardiogram (ECG) consists of a simple tool, of easy use and low cost, able to document success of the epicardial reperfusion and tissue reperfusion after primary PCI.

The persistence of ST-segment elevation on the ECG, despite the restoration of a normal epicardial flow, signifies a poor prognosis; such persistence is known to be associated with larger infarct size and higher combined rate of severe cardiovascular adverse events.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-28
• Last Update Submitted: 2019-03-28
• Study First Posted: 2019-03-29
• Last Update Posted: 2019-03-29
• Study Start: 2019-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

. patients with STEMI within 24 hours of chest pain.patients killip class 1 is included in this study

xclusion Criteria:

• killip II-IV
• Previous myocardial infarction
• Patients with left bundle branch block
• Patients with advanced cancer disease
• Patients qith contraindications to anti-coagulation
• Patients with sensitivity to clopidogrel

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thrombus aspiration group	Percutaneous primary coronary intervention	Will include 135 patients who will have PPCI with thrombus aspiration
Standard PPCI group	Percutaneous primary coronary intervention	Will include 135 patients who will have PPCI without thrombus aspiration

Primary Outcome Measures

Name	Time	Method
ST segment resolution	Within 90 minutes after the procedure	ST segment resolution in relation to the procedure used in primary percutaneous coronary intervention

Secondary Outcome Measures

Name	Time	Method
MACE	one week	the major adverse coronary events in correlation to ST segment resolution after primary percutaneous coronary intervention (recurrent angina, reinfarction, heart failure, major bleeding, disabling stroke or death) during the period of hospitalization.