Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

A comprehensive assessment of cardiac autonomic function and inflammatory profile will be performed in ACS patients with obstructive CAD (n=45) or with NO-CAD (n=45) 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 Design


Related Conditions & MeSH terms


NCT number NCT05756452
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Gaetano Antonio GL Lanza
Phone 06 3015 4432
Email gaetanoantonio.lanza@policlinicogemelli.it
Status Recruiting
Phase N/A
Start date February 17, 2023
Completion date February 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Terminated NCT02620202 - Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain