PCSK9 Polymorphism and Risk of Cardiac Rupture

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05503095
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetic analysis for PCSK9 polymorphisms

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
PCSK9 Polymorphism and Risk of Mechanical Complications Following Acute Myocardial Infarction
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
patients who develop cardiac rupture following acute myocardial infarction

Genetic: Genetic analysis for PCSK9 polymorphisms
Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

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

Genetic: Genetic analysis for PCSK9 polymorphisms
Determination of PCSK9 gene polymorphism and serum PCSK9 concentration

Outcome Measures

Primary Outcome Measures

  1. PCSK9 gene polymorphism [up to 1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Matteo Matteucci Varese Italy 21100

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT05503095
Other Study ID Numbers:
  • IT-VA-237-2021
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022