Predictive Value of PRECISE DAPT Score in STEMI Patients After Primary PCI

September 9, 2020 updated by: Madona Atef, Assiut University

The Predictive Value of PRECISE DAPT Score in Patients With ST Segment Elevation Myocardial Infarction (STEMI) After Primary Percutaneous Coronary Intervention (PPCI)

To investigate the predictive value of PRECISE DAPT score in relation to coronary slow flow & other short term major adverse cardiovascular events (MACE) post PPCI .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease (CAD) is the leading cause of death around the world and more than 4 million people die every year due to CAD in Europe.[1] The incidence of ST elevation myocardial infarction (STEMI) appears to be declining; however, it is still an important issue in cardiovascular medicine.[2] Initial risk assessment is important for STEMI to estimate adverse cardiovascular outcomes. Previous studies demonstrated that increased age, advanced Killip class, heart rate, arterial hypotension, increased serum creatinine, white blood cell counts, and hemoglobin levels were predictors of in-hospital and early mortality in patients with STEMI treated with primary percutaneous coronary intervention (PPCI).[3,4 ]Therefore, risk scores including the aforementioned parameters were developed to estimate mortality in patients with STEMI.

No-reflow is still a challenging major issue in the management of the patients with STEMI undergoing primary PCI. It is defined as inadequate myocardial perfusionthrough a given segment of the coronary circulation without angiographic evidence of mechanical vessel obstructionas [5] Angiographic no-reflow defined as less than Thrombolysis In Myocardial Infarction (TIMI) 3 flow [6] and angiographic success was defined as TIMI Grade 3 Flow .

PRECISE-DAPT score includes age, creatinine clearance, white blood cell counts, hemoglobin levels, and prior spontaneous bleeding [7]. All these factors have a close relationship with coronary artery disease (CAD) and complications [8-10]. Therefore, in this study, we aimed to evaluate the association of admission PRECISE-DAPT score with the development of slow flow & bleeding & othershort term cardiovascular complications that develop in patients with STEMI treated with primary PCI.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital eligible for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)

Description

Inclusion Criteria:1.Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital.[11].

2..Patients elegable for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)[12]

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Exclusion Criteria:1-late presentation with STEMI more than 12 hr & door to ballon more than 120 min including rescue PCI .

2- cardiogenic shock 3-Patients known to have autoimmune disease (e.g vasculitis ) 4- platelate count less than 100000 IU . 5- prothrombin concentration less than 60% 6- Patients taking triple anti thrombotics .

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up complications after PPCI
Time Frame: 3 months
calculating PRECISE DAPT score and follow up patients for three months whether these complications as coronary slow flow &primary MACE &secondary MACE &bleeding
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of PRECISE DAPT score
Time Frame: 3 months
Whether there is relation between PRECISE DAPT score &post PPCI short term complications or not
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Aly Mohamed, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

October 1, 2025

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISE DAPT score

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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