## Protocol Section
### Identification Module
**NCT ID:** NCT06424028

**Brief Title:** Acute Right Ventricular Infarction Registry

**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

#### Organization Study ID Info
**ID:** IRB-62/2023
#### Organization
**Class:** OTHER
**Full Name:** National Institute of Cardiovascular Diseases, Pakistan
### Status Module
#### Completion Date
**Date:** 2024-08-19

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-19

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Institute of Cardiovascular Diseases, Pakistan

#### Responsible Party

**Investigator Affiliation:** National Institute of Cardiovascular Diseases, Pakistan

**Investigator Full Name:** Dr. Rajesh Kumar

**Investigator Title:** Associate Professor Adult Cardiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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).

**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).

### Conditions Module

**Conditions:**

- Inferior Wall; Transmural Myocardial Infarction

- Right Ventricular Dysfunction

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 30 Days

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Consecutive patients presented with isolated inferior, infero-posterior and inferolateral wall MI with or without acute right ventricular infarction.

**Name:** Right Ventricular Infarct

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Atleast one adverse event, such as pump failure, cerebrovascular accident (CVA), stent thrombosis, major bleeding, contrast-induced nephropathy (CIN), ventricular arrhythmias, or mortality.

**Measure:** Composite adverse clinical outcome

**Time Frame:** Upto 30 days from admission

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rajeshnarsoolal@gmail.com

**Name:** Rajesh Kumar, MBBS, FCPS

**Phone:** +923337306090

**Role:** CONTACT

**Contact 2:**

**Email:** mkarim.nicvd@gmail.com

**Name:** Musa Karim, MSc

**Phone:** 03323646169

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Karachi

**Contacts:**

***Contact 1:***

- **Email:** rajeshnarsoolal@@gmail.com

- **Name:** Rajesh Kumar, MBBS, FCPS

- **Phone:** +923337306090

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** National Institute of Cardiovascular Diseases

**State:** Sindh

**Status:** RECRUITING

**Zip:** 75510

#### Overall Officials

**Official 1:**

**Affiliation:** National Institute of Cardiovascular Diaseses

**Name:** Rajesh Kumar, MBBS, FCPS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M20824

- Name: Ventricular Dysfunction

- Relevance: HIGH

- As Found: Ventricular Dysfunction

- ID: M20601

- Name: Ventricular Dysfunction, Right

- Relevance: HIGH

- As Found: Right Ventricular Dysfunction

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000018754

- Term: Ventricular Dysfunction

- ID: D000018497

- Term: Ventricular Dysfunction, Right

- ID: D000007238

- Term: Infarction

### Misc Info Module

- Version Holder: 2024-05-31
