Clinical trial NCT04565808: CHA2DS2-VASc Score as a Predictor of Thrombus Burden and Clinical Outcomes in Patients Undergoing PPCI.
Official title: CHA2DS2-VASc Score as a Predictor of Thrombus Burden, No-Reflow Phenomenon and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TIMI (Thrombolysis in myocardial infarction) flow after Primary Percutaneous Coronary Intervention (No-reflow phenomenon versus normal flow)
timeFrame: Baseline
Secondary outcomes:
measure: Early in-hospital complications and in-hospital mortality.
timeFrame: In-hospital stay duration ( up to 72 hours after intervention)
measure: Six months follow up
timeFrame: Six months follow up after hospital discharge
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.