NCT04785209

Brief Summary

Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores

Trial Health

87
On Track

Trial Health Score

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

Enrollment
640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

September 23, 2020

Last Update Submit

May 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participents with No reflow after PPCI and in hospital mortality

    No reflow: suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction. In hospital mortality

    Within 48 hours from admission

Study Arms (2)

No complication

Thrombolysis in myocardial infarction flow grade III flow after PPCI, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores

Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores

No reflow

No reflow phenomenon after pci on STEMI patients, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores

Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All STEMI patients presenting within 24 hrs of onset of symptoms

You may qualify if:

  • patients presenting with acute STEMI, within 24 hours of symptoms, fulfilling criteria for PPCI protocol in our facility

You may not qualify if:

  • patients presenting more than 24 hours of symptoms onset
  • patients not eligible for PPCI program in our facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

No-Reflow Phenomenon

Interventions

Mean Platelet VolumeLymphocyte Count

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Function TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCell SizeCell Physiological PhenomenaLeukocyte CountBlood Cell CountCell CountCytological TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Hamdy Shams elddin, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle invistigator

Study Record Dates

First Submitted

September 23, 2020

First Posted

March 5, 2021

Study Start

September 1, 2020

Primary Completion

February 28, 2021

Study Completion

May 1, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations