IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL

NCT07684768 | Completed

• 1 other identifier: 170-2023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective observational cohort study evaluated the effect of cardiac autonomic neuropathy (CAN) on perioperative ventricular repolarization, specifically QT and corrected QT (QTc) intervals, in patients undergoing elective coronary artery bypass grafting (CABG) surgery under general anesthesia. The study was conducted in a tertiary care university hospital between October 2023 and December 2024. Adult patients scheduled for isolated elective CABG surgery with sinus rhythm on preoperative electrocardiography were screened for eligibility. Cardiac autonomic function was assessed preoperatively using standardized Ewing's cardiovascular reflex tests. Patients were classified into two groups according to test results: CAN-positive (≥2 abnormal tests) and CAN-negative (\<2 abnormal tests). QT and QTc intervals were measured at predefined perioperative time points, including before anesthesia induction, baseline, before intubation, at 1 and 30 minutes after intubation, before cannulation, and 24 hours postoperatively. The primary objective was to compare perioperative QT and QTc interval changes between patients with and without CAN. Secondary outcomes included QT and QTc variability (ΔQT, ΔQTc) and the incidence of clinically significant QTc prolongation.

Conditions

Coronary Artery Disease; Cardiac Autonomic Neuropathy; QT Interval Prolongation

Keywords

Coronary Artery Bypass Grafting; Cardiac Autonomic Neuropathy; Ewing's Cardiovascular Reflex Tests; QT Interval; QTc Interval; General Anesthesia; Cardiac Surgery; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Perioperative change in corrected QT (QTc) interval

  Corrected QT (QTc) interval measured from lead II electrocardiography using Bazett's formula and compared between patients with and without cardiac autonomic neuropathy at predefined perioperative time points.

  Before anesthesia induction (baseline), immediately before tracheal intubation, 1 minute after intubation, 30 minutes after intubation, before cardiopulmonary bypass cannulation, and 24 hours after surgery.

Secondary Outcomes (4)

• QT interval variability (ΔQT)

  From anesthesia induction to 24 hours after surgery.

• Corrected QT interval variability (ΔQTc)

  From anesthesia induction to 24 hours after surgery.

• Incidence of QTc prolongation

  From anesthesia induction to 24 hours after surgery.

• Incidence of clinically significant QTc change

  From anesthesia induction to 24 hours after surgery.

Study Arms (2)

Cardiac Autonomic Neuropathy (CAN)-Positive

Participants with cardiac autonomic neuropathy diagnosed by Ewing's cardiovascular reflex tests (≥2 abnormal test results).

Cardiac Autonomic Neuropathy (CAN)-Negative

Participants without cardiac autonomic neuropathy (\<2 abnormal test results).

Eligibility Criteria

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

Study Population

Adult patients scheduled for elective isolated coronary artery bypass grafting (CABG) surgery under general anesthesia at a tertiary care university hospital.

You may qualify if:

• Age ≥18 years.
• Scheduled for elective isolated coronary artery bypass grafting (CABG).
• Sinus rhythm on preoperative 12-lead electrocardiography.
• Ability to undergo preoperative cardiovascular autonomic function assessment using Ewing's cardiovascular reflex tests.
• Written informed consent provided.

You may not qualify if:

• Previous cardiac surgery.
• Emergency CABG.
• Permanent pacemaker implantation.
• Atrial fibrillation or other clinically significant cardiac arrhythmias.
• Bundle branch block.
• Congenital long QT syndrome.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (2)

Sultangazi Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

Location

Health Science University, Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Tikkanen JT, Kentta T, Porthan K, Anttonen O, Eranti A, Aro AL, Kerola T, Rissanen HA, Knekt P, Heliovaara M, Holkeri A, Haukilahti A, Niiranen T, Hernesniemi J, Jula A, Nieminen MS, Myerburg RJ, Albert CM, Salomaa V, Huikuri HV, Junttila MJ. Risk of sudden cardiac death associated with QRS, QTc, and JTc intervals in the general population. Heart Rhythm. 2022 Aug;19(8):1297-1303. doi: 10.1016/j.hrthm.2022.04.016. Epub 2022 Apr 25.

  PMID: 35472593 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc prof.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: October 5, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)