Patients with Myocardial Infarction and non-obStructive coronary artEries MedDRA version: 20.0 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders System Organ Class: 100000004849
Conditions
Interventions
Product Name: TORVAST
Product Code: [TORVAST]
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATINA
CAS Number: 134523-00-5
Current Sponsor code: ATORVASTATINA
Concentration unit: mg milligra
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability to give informed consent to the study • Age > 18y • MINOCA diagnosis, defined as: o Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria): o Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel. o No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Inability or limited capacity to give informed consent to the study • Age < 18 y • Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded. • Patients with comorbidities having an expected survival <1-year will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved cardiovascular and quality of life outcomes, as well as in reduced healthcare related costs.;Secondary Objective: . To test wherever a plasma circulating biomarker profile may be able to differentiate between the different causes of MINOCA, helping to identify the underlying pathophysiological mechanisms and to stratify prognosis and response to medical therapy. • To test wherever cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification in MINOCA.;Primary end point(s): Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) at 1-year follow-up;Timepoint(s) of evaluation of this end point: 1 YEAR | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma
Outcome results
None listed