Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery
NCT ID: NCT03169608
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2017-04-03
2019-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Protection During Cardiac Surgery.
NCT03230136
Exploration of Cerebral Pathophysiology During and After CABG Using CPB
NCT02941380
Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery
NCT03517189
Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency
NCT00755248
A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.
NCT04107571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Autonomic dysfunction, baroreflex impairment and an inadequate microvascular perfusion may play a relevant role in triggering AF and AKI.
The perioperative characterization of the autonomic nervous system (ANS) and of the microcirculation might improve risk stratification and help in the prevention and early treatment of AF and AKI in CABG surgery.
The study aims are: i) to collect a number of perioperative indices describing the state of the ANS and of the microcirculation; ii) to assess the correlation among the different indices and their association with AF and AKI; iii) to develop a predictive model of postoperative outcomes (AF and AKI) accounting for perioperative autonomic indices and microcirculatory variables.
Population: 200 adults subjects scheduled for CABG surgery, with or without additional intervention Methods: perioperative (in the operating room) acquisition of ECG, arterial blood pressure, cerebral blood flow velocity as derived from transcranial doppler technique, microcirculation parameters as derived from sidestream dark field images Statistics: receiver operating characteristic (ROC) curve analysis with adequate cut-off values
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* sinus rhythm
* absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
* informed consent signed
* elective or urgent surgery
Exclusion Criteria
* absence of sinus rhythm
* pathologies affecting autonomic nervous system
* emergency surgery (to be operated immediately)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Policlinico S. Donato
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Ranucci
Director of Cardiothoracic Anesthesia and ICU Dept
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marco Ranucci, MD, FESC
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico S. Donato
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Villareal RP, Hariharan R, Liu BC, Kar B, Lee VV, Elayda M, Lopez JA, Rasekh A, Wilson JM, Massumi A. Postoperative atrial fibrillation and mortality after coronary artery bypass surgery. J Am Coll Cardiol. 2004 Mar 3;43(5):742-8. doi: 10.1016/j.jacc.2003.11.023.
Provenchere S, Plantefeve G, Hufnagel G, Vicaut E, de Vaumas C, Lecharny JB, Depoix JP, Vrtovsnik F, Desmonts JM, Philip I. Renal dysfunction after cardiac surgery with normothermic cardiopulmonary bypass: incidence, risk factors, and effect on clinical outcome. Anesth Analg. 2003 May;96(5):1258-1264. doi: 10.1213/01.ANE.0000055803.92191.69.
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.
Faes L, Porta A, Rossato G, Adami A, Tonon D, Corica A, Nollo G. Investigating the mechanisms of cardiovascular and cerebrovascular regulation in orthostatic syncope through an information decomposition strategy. Auton Neurosci. 2013 Nov;178(1-2):76-82. doi: 10.1016/j.autneu.2013.02.013. Epub 2013 Mar 27.
Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S13-9. doi: 10.1186/cc3753. Epub 2005 Aug 25.
Singh P, Porta A, Ranucci M, Cairo B, Gelpi F, Caruso R, Magon A, Baroni I, Conte G, Bari V. Identifying and preliminary validating patient clusters in coronary artery bypass grafting: integrating autonomic function with clinical and demographic data for personalized care. Eur J Cardiovasc Nurs. 2025 Sep 5;24(6):898-910. doi: 10.1093/eurjcn/zvaf059.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GR-2013-02356272
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GR2013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.