Post-Infarction Heart RuptureNCT05503095
PCSK9 Polymorphism and Risk of Cardiac Rupture
An observational study of Post-Infarction Heart Rupture and Gene Polymorphism, run by Maastricht University Medical Center at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Infarction Heart Rupture, Gene Polymorphism
- What is being tested?
- Genetic analysis for PCSK9 polymorphisms
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)
- clinical diagnosis of acute myocardial infarction complicated by cardiac rupture
Who cannot join
- absence of coronary artery disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Matteo Matteucci
Varese, 21100
Matteo Matteucci, MD, +39 3493556001, matteomatteucci87@gmail.com
Matteo Matteucci, MD
About this study
Official title: 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.
- Conditions
- Post-Infarction Heart Rupture, Gene Polymorphism
- Being tested
- Genetic analysis for PCSK9 polymorphisms
- Keywords
- PCSK9, Cardiac rupture
- Medical subject headings
- Heart Rupture, Post-Infarction, Heart Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysis for PCSK9 polymorphismsGenetic
Determination of PCSK9 gene polymorphism and serum PCSK9 concentration
| Study group | Role | What they receive |
|---|---|---|
| patients who develop cardiac rupture following acute myocardial infarction | Not described Receives: Genetic: Genetic analysis for PCSK9 polymorphisms | |
| patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture | Not described Receives: Genetic: Genetic analysis for PCSK9 polymorphisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCSK9 gene polymorphism
PCSK9 gene polymorphism (studied at patient admission and recovery for acute myocardial infarction)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Aug 2023
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Infarction Heart RuptureStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503095
- Sponsor's protocol ID
- IT-VA-237-2021
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK9 Polymorphism and Risk of Mechanical Complications Following Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05503095
- Acronym / sponsor ID
- IT-VA-237-2021
- Conditions
- Post-Infarction Heart Rupture, Gene Polymorphism
- Keywords
- PCSK9, Cardiac rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)
- clinical diagnosis of acute myocardial infarction complicated by cardiac rupture
Key exclusion criteria (1 listed)
- absence of coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic analysis for PCSK9 polymorphismsDetermination of PCSK9 gene polymorphism and serum PCSK9 concentration | Genetic | patients who develop cardiac rupture following acute myocardial infarction, patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture |
Primary outcome
PCSK9 gene polymorphism
Time frame: up to 1 year
PCSK9 gene polymorphism (studied at patient admission and recovery for acute myocardial infarction)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Infarction Heart Rupture and Gene Polymorphism, run by Maastricht University Medical Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCSK9 gene polymorphism (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.