Acute Right Ventricular Infarction Registry

Right Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424028
• Other study ID #: IRB-62/2023
• Status: Recruiting
• Start date: January 20, 2024
• Est. completion date: August 19, 2024

Study information

• Verified date: May 2024
• Source: National Institute of Cardiovascular Diseases, Pakistan
• Contact: Rajesh Kumar, MBBS, FCPS
• Phone: +923337306090
• Email: rajeshnarsoolal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 19, 2024
• Est. primary completion date: July 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Other:
• Right Ventricular Infarct
Consecutive patients presented with isolated inferior, infero-posterior and inferolateral wall MI with or without acute right ventricular infarction.

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite adverse clinical outcome	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