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ST Segment Resolution After Primary Percutaneous Coronary Intervention.

NCT ID: NCT03895983

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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ST Segment Elevation Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Thrombus aspiration group

Will include 135 patients who will have PPCI with thrombus aspiration

Percutaneous primary coronary intervention

Intervention Type PROCEDURE

Percutaneous primary coronary intervention

Standard PPCI group

Will include 135 patients who will have PPCI without thrombus aspiration

Percutaneous primary coronary intervention

Intervention Type PROCEDURE

Percutaneous primary coronary intervention

Interventions

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Percutaneous primary coronary intervention

Percutaneous primary coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amany Ragab Abdel mageed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AssiutU37

Identifier Type: -

Identifier Source: org_study_id