Status:
COMPLETED
Characterization of Patients With Post-ischemic Left Ventricular Dysfunction
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Left Ventricular Diastolic Dysfunction
Eligibility:
All Genders
18-80 years
Brief 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 successful...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
November 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT04699565
Start Date
November 18 2018
End Date
April 30 2021
Last Update
October 4 2023
Active Locations (10)
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1
IRCCS AOU San Martino
Genova, Italy
2
IRCCS Centro Cardiologico Monzino
Milan, Italy
3
IRCCS Fondazione Ca' Granda
Milan, Italy
4
IRCCS Istituto Auxologico Italiano
Milan, Italy