PCSK9 Polymorphism and Risk of Cardiac Rupture

NCT05503095 | Unknown

• 1 other identifier: IT-VA-237-2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Protein convertase subtilisin/kexin type 9 (PCSK9) plays a regulatory role in cholesterol homeostasis by promoting low-density lipoprotein receptor (LDLr) degradation. Although the vast majority of the studies have focused on the role of PCSK9 in LDLr expression in the liver, an increasing body of evidence suggests that PCSK9 gene is also present in extra-hepatic tissues. A recent publication showed for the first time that PCSK9 is expressed in the ischemic heart and the expression is highest in the zone bordering the infarcted areas. Furthermore, the expression of PCSK9 is maximal early, at 1 week of ischemia. Mechanical complications (or cardiac ruptures) are uncommon but potentially lethal sequelae of acute myocardium infarction (AMI) and are commonly associated with early mortality without appropriate surgical intervention. It's unknown why some patients develop these devasting complications following AMI, while others not. Interestingly, studies have shown that post-infarction cardiac rupture affect the border zone between the ischemic and normal area and occur within the first 3 to 5 days after AMI. Based on the aforementioned observations, it's likely to assume a relationship between PCSK9 expression and the development of post-AMI cardiac rupture. Therefore, the main purpose of the this project is to study the PCSK9 gene polymorphism and its association with cardiac rupture. Investigators hypothesize that PCSK9 expression/secretion and development of post-AMI cardiac rupture may be a part of the dynamic changes at cellular levels occurring in the ischemic heart of genetically predisposed patients.

Conditions

Post-Infarction Heart Rupture; Gene Polymorphism

Keywords

PCSK9; Cardiac rupture

Outcome Measures

Primary Outcomes (1)

• PCSK9 gene polymorphism

  PCSK9 gene polymorphism (studied at patient admission and recovery for acute myocardial infarction)

  up to 1 year

Study Arms (2)

patients who develop cardiac rupture following acute myocardial infarction

Genetic: Genetic analysis for PCSK9 polymorphisms

patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture

Genetic: Genetic analysis for PCSK9 polymorphisms

Interventions

Genetic analysis for PCSK9 polymorphisms GENETIC

Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

patients who develop cardiac rupture following acute myocardial infarction; patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who develop cardiac rupture following acute myocardial infarction (case group) and patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture (control group)

You may qualify if:

• clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)
• clinical diagnosis of acute myocardial infarction complicated by cardiac rupture

You may not qualify if:

• absence of coronary artery disease

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Matteo Matteucci

Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Heart Rupture, Post-Infarction; Heart Rupture

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 16, 2022
• Study Start: January 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: May 31, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

IT (1)