Acute Right Ventricular Infarction Registry

May 15, 2024 updated by: Dr. Rajesh Kumar, National Institute of Cardiovascular Diseases, Pakistan

Presentation, Management, Hospital-course, and Prognosis of Acute Right Ventricular Infarction: A Prospective Registry of Patients Presenting to the Largest Primary Percutaneous Coronary Intervention Centre of Pakistan

This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital and post-discharge (in 30 Days Prognosis).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity.Data will be collected for various patient, system, and procedure related characteristics with the help of a predefined structured proforma consisted of demographic data, clinical presentation, history and co-morbid conditions, and angiographic and procedural characteristics. All the recruited patients will be kept under observiton during the hospital stay and a telephonic follow-up will be carried out after 30-days of discharge and occurrence of the MACE will be recorded.

Univariate and multivariable binary logistic regression analysis will be performed to determine the clinical predictors of RVI. Odds ratio (OR) along with 95% confidence interval (CI) will be reported. The statistical significance criteria will be set as p-value<0.05.

For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Study Type

Observational

Enrollment (Estimated)

1000

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

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Recruiting
        • National Institute of Cardiovascular Diseases
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presented at a tertiary care hospital with Inferior and posterior wall MI with and without RV infarction undergoing PPCI who are fulfilling the eligibility criteria will be enrolled.

Description

Inclusion Criteria:

  • Patients of Inferior, infero-lateral and infero-posterior wall MI with and without RV infarction undergoing PPCI.
  • Both male and female patients.
  • Patients of age ≥ 18 years.

Exclusion Criteria:

• Patients who will not give consent for participation.

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
Composite adverse clinical outcome
Time Frame: Upto 30 days from admission
Atleast one adverse event, such as pump failure, cerebrovascular accident (CVA), stent thrombosis, major bleeding, contrast-induced nephropathy (CIN), ventricular arrhythmias, or mortality.
Upto 30 days from admission

Collaborators and Investigators

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

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Investigators

  • Principal Investigator: Rajesh Kumar, MBBS, FCPS, National Institute of Cardiovascular Diaseses

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 (Actual)

January 20, 2024

Primary Completion (Estimated)

July 19, 2024

Study Completion (Estimated)

August 19, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-62/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Hospital Medical Record number will be used as the patient identifier.

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.

Clinical Trials on Right Ventricular Dysfunction

Clinical Trials on Right Ventricular Infarct

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe