Left Ventricular Diastolic DysfunctionNCT04699565
Characterization of Patients With Post-ischemic Left Ventricular Dysfunction
An observational study of Left Ventricular Diastolic Dysfunction, run by IRCCS San Raffaele at 10 sites in Italy.
Trial summary
This is an observational, prospective, multicenter study (12 hospitals belonging to the Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI) treated successfully with primary percutaneous coronary intervention (PCI), that will be followed for 12 month after the acute event, in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Diastolic Dysfunction
- What is being tested?
- Cardiac magnetic resonance
- How many people
- 303 participants
- Where
- 10 sitesItaly
- Study dates
- 18 Nov 2018to 30 Apr 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) treated with effective primary angioplasty (PCI)
Who may be able to join
- Patients with STEMI (first episode) (defined according to European Society of Cardiology Guidelines 2017) with symptom onset within 12h (Class I), or >12h <48h (Class IIa), successfully treated by primary PCI.
- Patients with regional systolic dysfunction of 2 or more adjacent segments of the left ventricle, in the territory of the culprit artery, documented by echocardiogram on day 2 (Echo1) and confirmed at pre-discharge follow-up (Echo2).
Who cannot join
- Patients with documented prior myocardial infarction. In the event that cardiac MRI examination performed one month after STEMI shows areas of late enhancement even in segments of the left ventricle other than those subtended by the culprit artery, the patient will be allowed to continue the study if he or she does not have significant left ventricular dilatation and has no symptoms of heart failure;
- Patients with known cardiomyopathy;
- Patients with malignant neoplasia or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
- Patients with known active infectious disease;
- Patients who are unable to express valid informed consent at the time of enrollment;
- Patients with specific contraindications to the performance of cardiac MRI, including:
- Wearers of non-resonance-compatible devices; Previous surgery with placement of non-resonance-compatible vascular clips Claustrophobic patients; Patients with allergies and/or other specific contraindications to the use of paramagnetic contrast agents (gadolinium).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
IRCCS AOU San Martino
Genova
IRCCS Centro Cardiologico Monzino
Milan
IRCCS Fondazione Ca' Granda
Milan
IRCCS Istituto Auxologico Italiano
Milan
Paolo Camici
Milan
Irccs Sdn
Naples
IRCCS Policlinico San Matteo
Pavia
IRCCS Fondazione Policlinico Gemelli
Roma
IRCCS Policlinico San Donato
San Donato Milanese
IRCCS Multimedica
Sesto San Giovanni
About this study
This is an observational, prospective, multicenter study (12 hospitals belonging to the Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI) treated successfully with primary percutaneous coronary intervention (PCI), that will be followed for 12 month after the acute event, in order to ascertain the predictive value of myocardial viability measured with cardiac magnetic resonance (1.5 T; based on the transmural distribution of late enhancement in the infarcted segments) for the identification of left ventricular (LV) remodelling (REM) 6 months after STEMI.
Read the detailed description
The present study is divided into 3 appointments following the standard inpatient stay for the index event (STEMI).
T0: Inpatient stay for index STEMI. Assessment of eligibility for participation in the study:
- STEMI diagnosis
- Primary PCI
- Confirmation at second-day transthoracic echocardiogram and pre-discharge echocardiogram of left ventricular dysfunction
- Biomarker assay
Visit 1 (V1): between 30 and 40 days post-STEMI. Clinical evaluation and performance of cardiac MRI with paramagnetic contrast agent (gadolinium) for measurement of infarct territory size and myocardial viability.
Visit 2 (V2): 6 months after STEMI. Clinical evaluation and second cardiac MRI, without contrast medium, for measurement of left ventricular volumes and consequently for measurement of the presence of adverse left ventricular remodeling.
Visit 3 (V3): 12 months after STEMI. Clinical re-evaluation with collection of data regarding events of interest for secondary endpoint. Performance of transthoracic echocardiogram.
The examinations and follow-up visits included in this study are part of clinical practice for treatment and risk assessment in patients who suffered STEMI with the exception of cardiac MRI without contrast medium at 6 months.
Cardiac magnetic resonance (CMR) data (1 month and 6 months) will be centrally analyzed post hoc at the MRI center.
- Conditions
- Left Ventricular Diastolic Dysfunction
- Being tested
- Cardiac magnetic resonance
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonanceDiagnostic test
Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse left ventricular remodeling 6 month after index event
Adverse LV remodeling, defined as ≥12% increase in enddiastolic LV volume 6 months after STEMI
Diagnostic accuracy of CMR performed 1 month after STEMI to predict actual LV remodeling at 6 months
Measured: Six months
Secondary outcomes (5)
Incidence of cardiovascular adverse event 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling
Incidence of the composite endpoint of death from cardiovascular causes, re-infarction, nonfatal stroke, new coronary revascularization interventions, development of heart failure, and new hospitalizations for cardiovascular causes 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling.
Measured: Twelve months
Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability
Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability (i.e., percent left ventricular volume free of late enhancement (the total volume of the left ventricle showing no enhancement minus the volume of left ventricular myocardium with evidence of late enhancement).
Measured: Twelve months
Predictivity of the presence of microvascular obstruction
Predictivity of the presence of microvascular obstruction (MVO) in the infarcted area measured with CMR 1 month after STEMI on the development of LV remodeling at 6 months.
Measured: Six months
Predictivity of circulating biomarkers measured in the acute phase on the development of left ventricular remodeling six months after STEMI
Predictivity of circulating biomarkers [NT-proBNP, troponin T (TnT), PCR], measured in the acute phase on the development of left ventricular remodeling six months after STEMI.
Measured: Six months
Predictivity of circulating biomarkers measured in the acute phase on cardiovascular adverse events 12 months after STEMI
Predictivity of circulating biomarkers (NT-proBNP, TnT, PCR), measured in the acute phase on cardiovascular adverse events 12 months after STEMI.
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start18 Nov 2018
- Primary completion30 Sep 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Diastolic DysfunctionStudies 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Paolo G Camici MD FACC, IRCCS San Raffaele
- Investigators
- Paolo Camici, MD, FACC, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699565
- Sponsor's protocol ID
- VavirimS
- Status last verified
- Oct 2023
- First submitted
- 5 Jan 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Patients With Post-ischemic Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT04699565
- Acronym / sponsor ID
- VavirimS
- Conditions
- Left Ventricular Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 Jan 2021 (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.
This is an observational, prospective, multicenter study (12 hospitals belonging to the Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI) treated successfully with primary percutaneous coronary intervention (PCI), that will be followed for 12 month after the acute event, in order to ascertain the predictive value of myocardial viability measured with cardiac magnetic resonance (1.5 T; based on the transmural distribution of late enhancement in the infarcted segments) for the identification of left ventricular (LV) remodelling (REM) 6 months after STEMI.
Detailed description
The present study is divided into 3 appointments following the standard inpatient stay for the index event (STEMI).
T0: Inpatient stay for index STEMI. Assessment of eligibility for participation in the study:
- STEMI diagnosis
- Primary PCI
- Confirmation at second-day transthoracic echocardiogram and pre-discharge echocardiogram of left ventricular dysfunction
- Biomarker assay
Visit 1 (V1): between 30 and 40 days post-STEMI. Clinical evaluation and performance of cardiac MRI with paramagnetic contrast agent (gadolinium) for measurement of infarct territory size and myocardial viability.
Visit 2 (V2): 6 months after STEMI. Clinical evaluation and second cardiac MRI, without contrast medium, for measurement of left ventricular volumes and consequently for measurement of the presence of adverse left ventricular remodeling.
Visit 3 (V3): 12 months after STEMI. Clinical re-evaluation with collection of data regarding events of interest for secondary endpoint. Performance of transthoracic echocardiogram.
The examinations and follow-up visits included in this study are part of clinical practice for treatment and risk assessment in patients who suffered STEMI with the exception of cardiac MRI without contrast medium at 6 months.
Cardiac magnetic resonance (CMR) data (1 month and 6 months) will be centrally analyzed post hoc at the MRI center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) treated with effective primary angioplasty (PCI)
Key inclusion criteria (2 listed)
- Patients with STEMI (first episode) (defined according to European Society of Cardiology Guidelines 2017) with symptom onset within 12h (Class I), or >12h <48h (Class IIa), successfully treated by primary PCI.
- Patients with regional systolic dysfunction of 2 or more adjacent segments of the left ventricle, in the territory of the culprit artery, documented by echocardiogram on day 2 (Echo1) and confirmed at pre-discharge follow-up (Echo2).
Key exclusion criteria (7 listed)
- Patients with documented prior myocardial infarction. In the event that cardiac MRI examination performed one month after STEMI shows areas of late enhancement even in segments of the left ventricle other than those subtended by the culprit artery, the patient will be allowed to continue the study if he or she does not have significant left ventricular dilatation and has no symptoms of heart failure;
- Patients with known cardiomyopathy;
- Patients with malignant neoplasia or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
- Patients with known active infectious disease;
- Patients who are unable to express valid informed consent at the time of enrollment;
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 |
|---|---|---|
| Cardiac magnetic resonanceEvaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI | Diagnostic test | – |
Primary outcome
Adverse left ventricular remodeling 6 month after index event
Time frame: Six months
Adverse LV remodeling, defined as ≥12% increase in enddiastolic LV volume 6 months after STEMI Diagnostic accuracy of CMR performed 1 month after STEMI to predict actual LV remodeling at 6 months
5 secondary outcomes
Incidence of cardiovascular adverse event 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling
Time frame: Twelve months
Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability
Time frame: Twelve months
Predictivity of the presence of microvascular obstruction
Time frame: Six months
Predictivity of circulating biomarkers measured in the acute phase on the development of left ventricular remodeling six months after STEMI
Time frame: Six months
Predictivity of circulating biomarkers measured in the acute phase on cardiovascular adverse events 12 months after STEMI
Time frame: Twelve months
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 4 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Paolo Camici, MD, FACC principal investigator
Ospedale San Raffaele
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Diastolic Dysfunction, run by IRCCS San Raffaele at 10 sites 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 7 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 4 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 10 sites 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?
Adverse left ventricular remodeling 6 month after index event (time frame: Six months). 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 4 Oct 2023.