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IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL

IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL IN PATIENTS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFTING

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07684768
Acronym
QT interval
Enrollment
60
Registered
2026-07-06
Start date
2023-10-05
Completion date
2024-12-20
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Autonomic Neuropathy, Coronary Artery Disease, 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

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.

Detailed description

This prospective observational study was designed to evaluate the impact of cardiac autonomic neuropathy (CAN) on perioperative ventricular repolarization parameters, specifically QT and corrected QT (QTc) intervals, in patients undergoing elective coronary artery bypass grafting (CABG) surgery under general anesthesia. The study was conducted at a tertiary care university hospital within the Departments of Anesthesiology and Cardiovascular Surgery between October 2023 and December 2024. Patients scheduled for elective isolated 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. Based on test results, patients were classified into two groups: CAN-positive (≥2 abnormal tests) and CAN-negative (\<2 abnormal tests). QT and QTc intervals were measured at predefined perioperative time points, and variability of repolarization parameters was also assessed. The primary aim was to compare perioperative QT and QTc interval changes between patients with and without CAN.

Interventions

None listed

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative change in corrected QT (QTc) intervalBefore anesthesia induction (baseline), immediately before tracheal intubation, 1 minute after intubation, 30 minutes after intubation, before cardiopulmonary bypass cannulation, and 24 hours after surgery.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.

Secondary

MeasureTime frameDescription
QT interval variability (ΔQT)From anesthesia induction to 24 hours after surgery.Difference between the maximum and minimum QT interval recorded during the perioperative period.
Corrected QT interval variability (ΔQTc)From anesthesia induction to 24 hours after surgery.Difference between the maximum and minimum QTc interval recorded during the perioperative period.
Incidence of QTc prolongationFrom anesthesia induction to 24 hours after surgery.Number and proportion of patients with QTc interval ≥470 ms during the perioperative period.
Incidence of clinically significant QTc changeFrom anesthesia induction to 24 hours after surgery.Number and proportion of patients with QTc interval increase (ΔQTc) ≥60 ms during the perioperative period.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026