Linking Cardiac Autonomic Dysfunction and InfLammation in Patients With Acute Coronary Syndromes

NCT05756452 | Unknown

• 1 other identifier: 5480
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Myocardial Ischemia

Keywords

Subclinical inflammation; Autonomic nervous system; Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• The correlation between HRV and CRP parameters in ACS patients with obstructive CAD

  The primary endpoint of the study is to identify a difference in the correlation between HRV and CRP parameters in ACS patients with or without obstructive CAD. This study will be performed through a detailed history and clinical evaluation based on transthoracic Doppler echocardiography (TTDE) and 24-hour Holter ECG recording.

  12 months

• The correlation between HRV and CRP parameters in ACS patients without obstructive CAD

  The study is important to identify the differences between HRV and CRP parameters ACS patients without obtructive CAD. It is important to group several exams: sample blood, transthoracic Doppler echocardiography (TTDE) and 24-hour Holter ECG recording.

  12 months

Secondary Outcomes (1)

• Evaluate cardiac autonomic dysfunction associated to a systemic inflammation

  12 months

Study Arms (2)

Partecipants with ACS and obstructive CAD

EXPERIMENTAL

The study is to identify a difference in the correlation between HRV and CRP parameters in ACS patients with or without obstructive CAD

Diagnostic Test: Anamnesis and clinical evaluation

Partecipants with ACS without CAD, in a 1:1 ratio

EXPERIMENTAL

Evaluate whether cardiac autonomic dysfunction is associated with low-grade systemic inflammation, inflammasome-dependent activation of IL-18 and IL-1β, and Th1/Treg frequency, in patients with ACS with or without obstructive CAD on angiography

Diagnostic Test: Anamnesis and clinical evaluation

Interventions

Anamnesis and clinical evaluation DIAGNOSTIC_TEST

All partecipants 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.

Also known as: Transthoracic Doppler Echocardiography (TTDE);, 24-hour Holter ECG recording;, Peripheral venous blood sampling

Partecipants with ACS and obstructive CAD; Partecipants with ACS without CAD, in a 1:1 ratio

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Evidence of previous complete percutaneous revascularization;
• ACS, with or without CAD, experienced in the previous 3 months ±15 days;
• Signed written informed consent.

You may not qualify if:

• History of previous acute myocardial infarction (AMI);
• Prior surgical myocardial revascularization via coronary artery bypass graft (CABG);
• Previous incomplete percutaneous myocardial revascularization, as indicated by documentation of residual stenosis \>50% or FFR ≤0.8 in any epicardial vessel;
• Killip class III-IV in admission;
• Established cardiovascular disease (assessed by clinical evaluation, physical exam, 12-lead ECG, or transthoracic echocardiogram), such as congenital heart disease, cardiomyopathy, and severe valvular heart disease;
• Serious medical conditions, including severe renal insufficiency (eGFR \> 30 ml/min), hepatic insufficiency or cirrhosis, malignancies, COPD (GOLD stage III-IV), and acute or chronic inflammatory diseases;
• Refusal to sign the written informed consent to participate in the study.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Ischemia; Angina, Unstable

Interventions

Immunologic Memory; Physical Examination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adaptive Immunity; Immunity; Immune System Phenomena; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Gaetano Antonio GL Lanza

CONTACT

06 3015 4432; gaetanoantonio.lanza@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigators will enroll partecipants who have had an acute coronary syndrome (3 months ± 15 days before enrollment) followed up at the Cardiology Unit of the participating centers. Based on the coronary angiography results, partecipants will be divided into two groups: 1. patients with ACS and obstructive CAD; 2. patients with ACS without CAD, in a 1:1 ratio.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: February 17, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

IT (1)