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

CHA2DS2-VASc Score as a Predictor of Thrombus Burden, No-Reflow Phenomenon and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention

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

Study Overview

• Status: Unknown
• Conditions: STEMI
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Anticipated): 184

Contacts and Locations

• Study Contact: Name: Osman Ahmed Osman Ahmed, MBBCH/MBBS; Phone Number: +20 01068988494; Email: drosmanahmed1994@gmail.com
• Study Contact Backup: Name: Salma Taha Esmaeil, MD; Phone Number: +20 01003329108; Email: Esmaeil.salma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients who are diagnosed as STEMI and undergoing primary PCI in Assiut University hospitals, Cardiology department.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIMI (Thrombolysis in myocardial infarction) flow after Primary Percutaneous Coronary Intervention (No-reflow phenomenon versus normal flow)	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early in-hospital complications and in-hospital mortality.	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)	In-hospital stay duration ( up to 72 hours after intervention)
Six months follow up	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.	Six months follow up after hospital discharge

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Durante A, Camici PG. Novel insights into an "old" phenomenon: the no reflow. Int J Cardiol. 2015;187:273-80. doi: 10.1016/j.ijcard.2015.03.359. Epub 2015 Mar 26.
• Goto K, Lansky AJ, Nikolsky E, Fahy M, Feit F, Ohman EM, White HD, Mehran R, Bertrand ME, Desmet W, Hamon M, Stone GW. Prognostic significance of coronary thrombus in patients undergoing percutaneous coronary intervention for acute coronary syndromes: a subanalysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. JACC Cardiovasc Interv. 2011 Jul;4(7):769-77. doi: 10.1016/j.jcin.2011.02.019.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CHA2DS2-VASc Score in PPCI

Drug and device information, study documents

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