ST Segment Resolution After Primary Percutaneous Coronary Intervention. (STresolution)

SsST Segment Resolution After Primary Percutaneous Coronary Intervention. A Comparison Between Primary Percutaneous Coronary Intervention With and Without Thrombus Aspiration

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

Study Overview

• Status: Unknown
• Conditions: ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Percutaneous primary coronary intervention

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 Type: Observational
• Enrollment (Anticipated): 270

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

270 patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thrombus aspiration group; Will include 135 patients who will have PPCI with thrombus aspiration	Procedure: Percutaneous primary coronary intervention; Percutaneous primary coronary intervention
Standard PPCI group; Will include 135 patients who will have PPCI without thrombus aspiration	Procedure: Percutaneous primary coronary intervention; Percutaneous primary coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ST segment resolution	ST segment resolution in relation to the procedure used in primary percutaneous coronary intervention	Within 90 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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.	one week

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: AssiutU37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No