- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503095
PCSK9 Polymorphism and Risk of Cardiac Rupture
PCSK9 Polymorphism and Risk of Mechanical Complications Following Acute Myocardial Infarction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Varese, Italy, 21100
- Recruiting
- Matteo Matteucci
-
Contact:
- Matteo Matteucci, MD
- Phone Number: +39 3493556001
- Email: matteomatteucci87@gmail.com
-
Principal Investigator:
- Matteo Matteucci, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients who develop cardiac rupture following acute myocardial infarction
|
Determination of PCSK9 gene polymorphism and serum PCSK9 concentration
|
patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture
|
Determination of PCSK9 gene polymorphism and serum PCSK9 concentration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCSK9 gene polymorphism
Time Frame: up to 1 year
|
PCSK9 gene polymorphism (studied at patient admission and recovery for acute myocardial infarction)
|
up to 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IT-VA-237-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Infarction Heart Rupture
-
Maastricht University Medical CenterCompletedPost-Infarction Ventricular Septal Defect | Post-Infarction Heart Rupture | Post-Infarction Mitral Papillary Muscle RuptureNetherlands
-
Maastricht University Medical CenterCompletedVentricular Septal Rupture | Papillary Muscle Rupture | Free Wall Rupture, HeartNetherlands
-
Chinese PLA General HospitalCompleted
-
Seoul National University HospitalAarhus University Hospital; Ulsan University Hospital; Inje University; Keimyung... and other collaboratorsUnknownMyocardial Infarction | Acute Coronary Syndrome | Plaque, Atherosclerotic | Rupture, SpontaneousKorea, Republic of
-
Boston Scientific CorporationCompletedPost Myocardial InfarctionUnited States
-
University of LeicesterUniversity Hospitals, Leicester; Freemasons' Medical Research FundingCompletedPost Myocardial InfarctionUnited Kingdom
-
Novartis PharmaceuticalsWithdrawnPost Myocardial Infarction
-
Nikolaj EldrupAarhus University Hospital; Aarhus University Hospital SkejbyCompletedAbdominal Aortic AneurysmDenmark
-
University College, LondonUniversity College London Hospitals; Surrey and Sussex Healthcare NHS TrustCompletedPost Procedural Myocardial Infarction
-
Centre Hospitalier Universitaire de NīmesDedienne Sante S.A.S.Terminated
Clinical Trials on Genetic analysis for PCSK9 polymorphisms
-
University Hospital, LilleUniversity of Lausanne Hospitals; Seventh Framework ProgrammeCompletedCandidemia | Genetic Predisposition to Disease | Invasive CandidiasisFrance
-
Egas Moniz - Cooperativa de Ensino Superior, CRLOral Reconstruction FoudationRecruiting
-
Fondazione Don Carlo Gnocchi OnlusRecruitingBrain Injuries | Disorder of ConsciousnessItaly
-
Poitiers University HospitalCompletedDevelopment Abnormalies | Inclusion on Clinical Criteria of the SyndromeFrance
-
University of AberdeenRecruitingTakotsubo CardiomyopathyUnited Kingdom
-
University Hospital, Clermont-FerrandHeart and Research Foundation; French Coronary Atheroma and Interventional...CompletedSpontaneous Coronary Artery Dissection | Spontaneous Coronary Artery HaematomaFrance
-
Leonardo Paroche de MatosProf. Dr. José Antônio Silva Júnior; Msc. Allan Luis Barboza AtumNot yet recruitingSars-CoV-2 InfectionBrazil
-
University of Sao Paulo General HospitalRecruitingMicrobial Colonization | Amyloidosis, Hereditary, Transthyretin-RelatedBrazil
-
Hackensack Meridian HealthUppsala University, Sweden (Department of Immunology, Genetics and Pathology)Suspended
-
University Hospital, BordeauxCompletedPain | Fabry's DiseaseFrance