PCSK9 Polymorphism and Risk of Cardiac Rupture

NCT ID: NCT05503095

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Infarction Heart Rupture Gene Polymorphism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who develop cardiac rupture following acute myocardial infarction

Genetic analysis for PCSK9 polymorphisms

Intervention Type GENETIC

Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

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

Genetic analysis for PCSK9 polymorphisms

Intervention Type GENETIC

Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

Interventions

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Genetic analysis for PCSK9 polymorphisms

Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* absence of coronary artery disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Matteo Matteucci

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Matteo Matteucci, MD

Role: primary

+39 3493556001

Other Identifiers

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IT-VA-237-2021

Identifier Type: -

Identifier Source: org_study_id

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