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

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04565808
• Other study ID #: CHA2DS2-VASc Score in PPCI
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Osman Ahmed Osman Ahmed, MBBCH/MBBS
• Phone: +20 01068988494
• Email: drosmanahmed1994[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• STEMI
• Thrombosis

Intervention

Procedure:
• primary percutaneous coronary intervention
Primary Percutaneous Coronary Intervention (PPCI), also known as angioplasty or coronary angioplasty, is a procedure used to diagnose and treat the narrowed coronary arteries of the heart.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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