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NCT Number: NCT07684768

IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Cardiac Autonomic Neuropathy Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms QT Interval Prolongation Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Science University, Haseki Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Perioperative change in corrected QT (QTc) interval

    Time frame: 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.

    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 outcomes

  1. QT interval variability (ΔQT)

    Time frame: From anesthesia induction to 24 hours after surgery.

    Difference between the maximum and minimum QT interval recorded during the perioperative period.

  2. Corrected QT interval variability (ΔQTc)

    Time frame: From anesthesia induction to 24 hours after surgery.

    Difference between the maximum and minimum QTc interval recorded during the perioperative period.

  3. Incidence of QTc prolongation

    Time frame: From anesthesia induction to 24 hours after surgery.

    Number and proportion of patients with QTc interval ≥470 ms during the perioperative period.

  4. Incidence of clinically significant QTc change

    Time frame: From anesthesia induction to 24 hours after surgery.

    Number and proportion of patients with QTc interval increase (ΔQTc) ≥60 ms during the perioperative period.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: QT interval

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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