Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction

NCT03523624 | Completed

• 1 other identifier: eXIST-DCTV
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In medical practice, a combination of clinical exam, electrocardiograms, circulating biomarkers, and imaging is used to gain insights on the prognosis after myocardial infarction. Novel molecular non-invasive tools are needed that help clinicians overcome the adverse events of post-myocardial infarction remodelling and thereby achieve improved therapy for its prevention. Coagulation factor XIII (FXIII) decay has been linked to major adverse cardiac events (MACE) in patients with acute coronary syndromes. Given the correlation between both intramyocardial haemorrhage and microvascular damage with acute phase complications in ST-elevation myocardial infarction, we hypothesise that excessive FXIII decay within the first week may predict acute phase outcomes in these patients. If this holds true, FXIII determination could be used as diagnostic and prognostic tool.

Conditions

Factor XIII Deficiency; ST-Elevation Myocardial Infarction; Myocardial Haemorrhage; Coronary Microvascular Disease

Keywords

factor XIII; intramyocardial haemorrhage; microvascular injury; STEMI; cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• FXIII decay correlation with intramyocardial haemorrhage/microvascular damage

  FXIII decay will be correlated with intramyocardial haemorrhage/microvascular damage as assessed by cardiac magnetic resonance imaging

  average of 6 days

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 that present in the Padova University Hospital Coronary Care Unit with a ST-elevation myocardial infarction will be screened

You may qualify if:

• patients with the clinical presentation of ST-elevation myocardial infarction within 12 h of symptom onset and with persistent ST-segment elevation or new or presumed new left bundle branch block and undergoing primary percutaneous coronary intervention (PCI)

You may not qualify if:

• patients with late presentation ST-elevation myocardial infarction (beyond the first 12h after onset of symptoms) or ineligible for mechanical reperfusion therapy
• contraindications to cardiac magnetic resonance
• pregnancy

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padua, Cardiology Clinic

Padua, PD, 35128, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma will be stocked for FXIII determination

MeSH Terms

Conditions

Factor XIII Deficiency; ST Elevation Myocardial Infarction; Microvascular Angina

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: November 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: January 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

IT (1)