CHA2DS2-VASc Score as a Predictor of Thrombus Burden and Clinical Outcomes in Patients Undergoing PPCI.

• Conditions: STEMI

• Registration Number: NCT04565808
• Lead Sponsor: Assiut University

Brief Summary

Aim of the work is to evaluate the use CHA2DS2-VASc score in predicting no-reflow phenomenon and its impact on short term primary percutaneous coronary intervention outcomes (in-hospital mortality) and long term (6 months) incidence of MACE ( major adverse cardiac event ) in patients with ST segment elevation Myocardial infarction who underwent primary primary percutaneous coronary intervention

Detailed Description

Large intracoronary thrombus burden is known to be associated with reduced procedural success during the Primary Percutaneous Coronary Intervention (PPCI), larger infarct size, increased ischemic complications and mortality. No-Reflow phenomenon is related to higher incidence of complications, and short- and long-term morbidity and mortality in acute STEMI patients.

Although many risk factors were suggested, Tragically there's no widely accepted risk stratification method to anticipate these complications.

CHA2DS2-VASc score is a sum of several risk factors for thromboembolism. It is considered a clinical indicator of thromboembolic diseases and is recommended by the current guidelines for the estimation of thromboembolic events in patients with atrial fibrillation.

In this study, we evaluate the use CHA2DS2-VASc score as a novel rapid simple tool for predicting No-reflow and clinical outcomes among patients with STEMI who underwent primary PCI.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25
• Study Start: 2021-01
• Primary Completion: 2022-04
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Subjects with STEMI and undergoing primary Primary percutaneous coronary intervention.
• Patient Loaded pre-procedural with using with Aspirin 300 mg plus Ticagrelor 180 mg or Clopidogrel 600 mg.

Exclusion Criteria

• Patients with chest pain more than 48 hours
• Patients not eligible for primary PCI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TIMI (Thrombolysis in myocardial infarction) flow after Primary Percutaneous Coronary Intervention (No-reflow phenomenon versus normal flow)	Baseline	Evaluation of the use of CHA2DS2-VASc score in predicting no-reflow phenomenon in patients with ST segment elevation myocardial infarction and undergoing Primary Percutaneous Coronary Intervention

Secondary Outcome Measures

Name	Time	Method
Early in-hospital complications and in-hospital mortality.	In-hospital stay duration ( up to 72 hours after intervention)	Evaluation of the use of CHA2DS2-VASc score in predicting In-hospital incidence of MACE (including cardiovascular death, myocardial infarction, hospitalization because of heart failure and ischemic stroke)
Six months follow up	Six months follow up after hospital discharge	Evaluation of the use of CHA2DS2-VASc score in predicting incidence of major adverse cardiovascular events which includes cardiovascular death, myocardial infarction, hospitalization because of heart failure and ischemic stroke during a Follow up period of 180 days after undergoing PPCI.