NCT04565808

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

September 16, 2020

Last Update Submit

September 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Early in-hospital complications and in-hospital mortality.

    In-hospital stay duration ( up to 72 hours after intervention)

  • Six months follow up

    Six months follow up after hospital discharge

Interventions

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.

Also known as: coronary angioplasty

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 25838230BACKGROUND
  • 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.

    PMID: 21777885BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

Osman Ahmed Osman Ahmed, MBBCH/MBBS

CONTACT

Salma Taha Esmaeil, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 25, 2020

Study Start

January 1, 2021

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

September 25, 2020

Record last verified: 2020-09