Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511817
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Myocardial Infarction With Non-obstructive Coronary Arteries Italian Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Myocardial Infarction With Non-obstructive Coronary Arteries Italian Observational
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINOCA-IT
Brief Summary:
Acute coronary syndromes have been extensively studied in recent decades focusing mainly on myocardial infarctions with obstructive coronary artery disease and early revascularisation strategies However the extensive use of highly sensitive troponin tests and coronary angiography has revealed a substantial group of patients with myocardial infarction without significant coronary stenosis 50 This group is referred to as myocardial infarction with non-obstructive coronary arteries MINOCA MINOCA are defined by evidence of a myocardial infarction with normal or near-normal coronary arteries on angiography in the absence of an alternative diagnosis specific to the clinical presentation eg sepsis myocarditis pulmonary embolism MINOCA may present with different aetiologies including coronary plaque ruptureerosion epicardial or microvascular spasm and coronary embolism Therefore the diagnosis of MINOCA must be considered a working diagnosis which not only requires but warrants further investigation to determine the underlying cause In fact the investigation of MINOCA is conducted on two levels first by excluding disorders that mimic myocardial infarction and then by identifying the cause responsible for MINOCA In order to identify the various underlying causes of MINOCA a cardiac MRI andor coronary vascular imaging approach with OCT or intravascular ultrasound IVUS and a coronary functional assessment of microvascular function as well as the provocation of coronary spasms by acetylcholine testing are recommended Moreover the clear definition of the aetiology is of great importance considering the role they play in the most appropriate therapeutic choice
Therefore the creation of an Italian national database could implement not only the knowledge of this clinical condition but also its management and consequent prognosis
Therefore the creation of an Italian national database could implement not only the knowledge of this clinical condition but also its management and consequent prognosis
Detailed Description:
Although the prevalence of MINOCA is about 5-25 of all myocardial infarctions and the prognosis is now recognised as inauspicious with a one-year all-cause mortality rate of 35 data on the specific demographics clinical features etiopathogenetic factors and prognosis of MINOCA patients are still currently unavailable in Italy The aim of this study is to assess in a real-world setting prevalence demographics possible aetiological causes and diagnostic therapeutic and prognostic data of MINOCA patients in Italy by creating a national database with ambispectively collected data The collection of therapeutic and management data on MINOCA in an ambispective manner - retrospective and prospective patients - will make it possible to evaluate the hospital management of MINOCA and its association with patient prognosis over time This database will serve to determine the incidence and characteristics of this pathology In addition it will make it possible to evaluate the nationwide management of patients with MINOCA thus considering both the diagnostic aspects aimed at defining the aetiology and cascade the treatments used and the patients outcomes As in all observational studies the assessment of the riskbenefit ratio of patients with myocardial infarction the administration of medical treatment and the management of the disease and treatment-related clinical events are the responsibility of the physician treating the patient Since the purpose of the work only involves the collection of data participation in this research will not entail any additional risk for the patient The collection of actual data should provide valuable information on the demographics aetiology and prognosis of MINOCA patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None