Factor XIII DeficiencyeXISTNCT03523624
Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction
An observational study of Factor XIII Deficiency and ST-Elevation Myocardial Infarction, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Factor XIII Deficiency, ST-Elevation Myocardial Infarction, Myocardial Haemorrhage
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2015to 1 Jan 2022
- 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 that present in the Padova University Hospital Coronary Care Unit with a ST-elevation myocardial infarction will be screened
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background:
The reduction of mortality in acute myocardial infarction (AMI) is achieved by the efficacy of the current therapeutic strategies focused on an early reopening of the culprit coronary artery, by either medical or mechanical reperfusion. Primary percutaneous coronary intervention (PCI) represents the most effective way to limit infarct size and reduce transmural extension of necrosis. Although coronary artery recanalization represents the most effective way to reduce infarct size, the process of reperfusion may itself produce a series of consequences including intramyocardial haemorrhage (IMH) and microvascular injury (MVO) contributing to the 'no reflow' phenomenon. MVO is an early event followed by intramyocardial haemorrhage that plays a role later in reperfusion injury. Both luminal obstruction (microvascular damage by neutrophil plugging, platelets and emboli) and external compression (by oedema and haemorrhage) are allegedly linked with no-reflow, however, the real mechanism underlying this complex time-sensitive phenomenon remains to be fully understood. MVO and IMH in ST-elevation myocardial infarction are independent predictor of adverse left ventricle remodelling, independently of the initial infarct size, and predict MACE.
The diagnosis of no-reflow is usually made when post-procedural thrombolysis in myocardial infarction (TIMI) flow is <3, or in the case of a TIMI flow of 3 when myocardial blush grade is 0 or 1, or when ST resolution within 4 h of the procedure is <70%. It can be assessed using cardiac magnetic resonance (CMR) techniques, where they appear as dark zones on delayed post-contrast sequences or contrast echocardiography.
FXIII is a protransglutaminase that becomes activated by thrombin and catalyses the formation of crosslinked fibrin mesh in the final stage of the clotting cascade. Blood coagulation FXIII is thought to play a role in wound healing and tissue repair. FXIII is present in plasma, platelets, monocytes, and macrophages, all of which are involved in infarct healing. In an experimental model, mice lacking FXIII suffer from impaired wound healing and fatal rupture of the left ventricle after myocardial infarction. This phenomenon was observed in 100% of homozygous and, interestingly, in 100% of the heterozygous FXIII-knockout mice, despite a FXIII plasma level of 70%. Replenishment of FXIII during the 5-day acute and subacute period of infarct healing restored survival rates of FXIII-deficient mice to that of wild-type mice. In addition, reduced FXIII activity imaged via single photon emission computed tomography predicted adverse infarct healing after MI in mice. In contrast, increased intracardiac FXIII activity via induction of high FXIII zymogen plasma levels improved cardiac healing. Moreover, FXIII levels were significantly diminished in myocardial biopsies of human ruptured MI. In a case series of 25 patients with acute MI, a mean decrease of initially normal FXIII plasma values by 25% was reported during the first week after the ischemic event. During the first week after MI, an acute phase reduction in FXIII plasma levels has been described, with the nadir of reduction on day 3-6 after the acute event.
FXIII thus seems to mediate the formation of a well-cemented scar, reducing MVO and IMH and improve healing and left ventricle remodelling.
Aim of the study:
We will perform a prospective observational study to identify how the differences in FXIII levels in ST-elevation myocardial infarction patients relate with intramyocardial haemorrhage and microvascular damage as detected by cardiac magnetic resonance.
- Conditions
- Factor XIII Deficiency, ST-Elevation Myocardial Infarction, Myocardial Haemorrhage, Coronary Microvascular Disease
- Keywords
- factor XIII, intramyocardial haemorrhage, microvascular injury, STEMI, cardiac magnetic resonance
- Medical subject headings
- Factor XIII Deficiency, ST Elevation Myocardial Infarction, Microvascular Angina
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Nov 2015
- Primary completion1 Mar 2019
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Factor XIII DeficiencyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittorio Pengo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523624
- Sponsor's protocol ID
- eXIST-DCTV
- Acronym
- eXIST
- Status last verified
- May 2022
- First submitted
- 1 May 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03523624
- Acronym / sponsor ID
- eXIST / eXIST-DCTV
- Conditions
- Factor XIII Deficiency, ST-Elevation Myocardial Infarction, Myocardial Haemorrhage, Coronary Microvascular Disease
- Keywords
- factor XIII, intramyocardial haemorrhage, microvascular injury, STEMI, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 14 May 2018 (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.
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.
Detailed description
Background:
The reduction of mortality in acute myocardial infarction (AMI) is achieved by the efficacy of the current therapeutic strategies focused on an early reopening of the culprit coronary artery, by either medical or mechanical reperfusion. Primary percutaneous coronary intervention (PCI) represents the most effective way to limit infarct size and reduce transmural extension of necrosis. Although coronary artery recanalization represents the most effective way to reduce infarct size, the process of reperfusion may itself produce a series of consequences including intramyocardial haemorrhage (IMH) and microvascular injury (MVO) contributing to the 'no reflow' phenomenon. MVO is an early event followed by intramyocardial haemorrhage that plays a role later in reperfusion injury. Both luminal obstruction (microvascular damage by neutrophil plugging, platelets and emboli) and external compression (by oedema and haemorrhage) are allegedly linked with no-reflow, however, the real mechanism underlying this complex time-sensitive phenomenon remains to be fully understood. MVO and IMH in ST-elevation myocardial infarction are independent predictor of adverse left ventricle remodelling, independently of the initial infarct size, and predict MACE.
The diagnosis of no-reflow is usually made when post-procedural thrombolysis in myocardial infarction (TIMI) flow is <3, or in the case of a TIMI flow of 3 when myocardial blush grade is 0 or 1, or when ST resolution within 4 h of the procedure is <70%. It can be assessed using cardiac magnetic resonance (CMR) techniques, where they appear as dark zones on delayed post-contrast sequences or contrast echocardiography.
FXIII is a protransglutaminase that becomes activated by thrombin and catalyses the formation of crosslinked fibrin mesh in the final stage of the clotting cascade. Blood coagulation FXIII is thought to play a role in wound healing and tissue repair. FXIII is present in plasma, platelets, monocytes, and macrophages, all of which are involved in infarct healing. In an experimental model, mice lacking FXIII suffer from impaired wound healing and fatal rupture of the left ventricle after myocardial infarction. This phenomenon was observed in 100% of homozygous and, interestingly, in 100% of the heterozygous FXIII-knockout mice, despite a FXIII plasma level of 70%. Replenishment of FXIII during the 5-day acute and subacute period of infarct healing restored survival rates of FXIII-deficient mice to that of wild-type mice. In addition, reduced FXIII activity imaged via single photon emission computed tomography predicted adverse infarct healing after MI in mice. In contrast, increased intracardiac FXIII activity via induction of high FXIII zymogen plasma levels improved cardiac healing. Moreover, FXIII levels were significantly diminished in myocardial biopsies of human ruptured MI. In a case series of 25 patients with acute MI, a mean decrease of initially normal FXIII plasma values by 25% was reported during the first week after the ischemic event. During the first week after MI, an acute phase reduction in FXIII plasma levels has been described, with the nadir of reduction on day 3-6 after the acute event.
FXIII thus seems to mediate the formation of a well-cemented scar, reducing MVO and IMH and improve healing and left ventricle remodelling.
Aim of the study:
We will perform a prospective observational study to identify how the differences in FXIII levels in ST-elevation myocardial infarction patients relate with intramyocardial haemorrhage and microvascular damage as detected by cardiac magnetic resonance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present in the Padova University Hospital Coronary Care Unit with a ST-elevation myocardial infarction will be screened
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FXIII decay correlation with intramyocardial haemorrhage/microvascular damage
Time frame: average of 6 days
FXIII decay will be correlated with intramyocardial haemorrhage/microvascular damage as assessed by cardiac magnetic resonance imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
Related trials for Factor XIII Deficiency
RecruitingPhase 4
SWIFT - SWIss Factor XIII Trial in PPH
Postpartum Hemorrhage, Coagulation Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Factor XIII Deficiency and ST-Elevation Myocardial Infarction, run by University of Padova 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FXIII decay correlation with intramyocardial haemorrhage/microvascular damage (time frame: average of 6 days). 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 25 May 2022.