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

September 24, 2020 updated by: Osman Ahmed Osman Ahmed, Assiut University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TIMI (Thrombolysis in myocardial infarction) flow after Primary Percutaneous Coronary Intervention (No-reflow phenomenon versus normal flow)
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early in-hospital complications and in-hospital mortality.
Time Frame: In-hospital stay duration ( up to 72 hours after intervention)
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)
Six months follow up
Time Frame: Six months follow up after hospital discharge
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHA2DS2-VASc Score in PPCI

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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