Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05756452
Status:
RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-02-21
Brief Title:
Linking Cardiac Autonomic Dysfunction and InfLammation in Patients With Acute Coronary Syndromes
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Linking Cardiac Autonomic Dysfunction and InfLammation in Patients With Acute Coronary Syndromes a Complex Puzzle to be Solved With Potential Therapeutic Implications CADILACS Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADILACS
Brief Summary:
Subclinical inflammation plays a critical role in all stages of the atherosclerotic process from the initiation of the fatty streaks to the development of plaque instability and rupture causing myocardial ischemia and acute coronary syndromes ACS
A few studies have suggested that the autonomic nervous system ANS and the inflammatory response are intimately linked Accordingly a relation between impaired cardiac autonomic tone and increased markers of inflammation has been reported in healthy subjects as well as in patients with type 1 diabetes mellitus chronic coronary syndrome or decompensated heart failure
To get insight in the controversial relationship between cardiac autonomic dysfunction and inflammation in patients with ACS both with and without obstructive CAD and assess the precise mechanisms and molecular pathways by which these two pathophysiological conditions mutually influence each other to characterize their prognostic implications and identify possible targets for novel therapeutic strategies
A few studies have suggested that the autonomic nervous system ANS and the inflammatory response are intimately linked Accordingly a relation between impaired cardiac autonomic tone and increased markers of inflammation has been reported in healthy subjects as well as in patients with type 1 diabetes mellitus chronic coronary syndrome or decompensated heart failure
To get insight in the controversial relationship between cardiac autonomic dysfunction and inflammation in patients with ACS both with and without obstructive CAD and assess the precise mechanisms and molecular pathways by which these two pathophysiological conditions mutually influence each other to characterize their prognostic implications and identify possible targets for novel therapeutic strategies
Detailed Description:
A comprehensive assessment of cardiac autonomic function and inflammatory profile will be performed in ACS patients with obstructive CAD n45 or with NO-CAD n45 at coronary angiography In the sub-acute phase 1 to 6 months after the ACS all patients will undergo a global echocardiographic evaluation a 24-hour ECG Holter recording to assess HRV and blood samples collection for neurotransmitter measurements platelet activation and reactivity evaluation and inflammatory profile assessment by proteomics analysis inflammasome activity evaluation NLRP3 pro-IL-18 and pro-IL-1β expression level by qPCR and epigenetic analysis A follow-up to establish clinical conditions of patients will be done after 12 months by direct clinical visit trans-thoracic echocardiogram to evaluate cardiac remodeling HRV assessment by 24-hour ECG Holter recording and blood sample collection to evaluate the inflammatory profile as it was assessed at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None