Coronary Artery DiseaseQT intervalNCT07684768
IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL
An observational study of Coronary Artery Disease and Cardiac Autonomic Neuropathy, run by Haseki Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Cardiac Autonomic Neuropathy, QT Interval Prolongation
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Oct 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective isolated coronary artery bypass grafting (CABG) surgery under general anesthesia at a tertiary care university hospital.
Who may be able to join
- 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.
Who cannot join
- Previous cardiac surgery.
- Emergency CABG.
- Permanent pacemaker implantation.
- Atrial fibrillation or other clinically significant cardiac arrhythmias.
- Bundle branch block.
- Congenital long QT syndrome.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sultangazi Haseki Training and Research Hospital
Istanbul, 34265
Health Science University, Haseki Training and Research Hospital
Istanbul
About this study
Official title: IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL IN PATIENTS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFTING
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.
Read the 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.
- Keywords
- Coronary Artery Bypass Grafting, Cardiac Autonomic Neuropathy, Ewing's Cardiovascular Reflex Tests, QT Interval, QTc Interval, General Anesthesia, Cardiac Surgery, Arrhythmia
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Difference between the maximum and minimum QT interval recorded during the perioperative period.
Measured: From anesthesia induction to 24 hours after surgery.
Corrected QT interval variability (ΔQTc)
Difference between the maximum and minimum QTc interval recorded during the perioperative period.
Measured: From anesthesia induction to 24 hours after surgery.
Incidence of QTc prolongation
Number and proportion of patients with QTc interval ≥470 ms during the perioperative period.
Measured: From anesthesia induction to 24 hours after surgery.
Incidence of clinically significant QTc change
Number and proportion of patients with QTc interval increase (ΔQTc) ≥60 ms during the perioperative period.
Measured: From anesthesia induction to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start5 Oct 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Uzman, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684768
- Sponsor's protocol ID
- 170-2023
- Acronym
- QT interval
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35472593
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF CARDIAC AUTONOMIC NEUROPATHY ON QT AND QTC INTERVAL IN PATIENTS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFTING
- ClinicalTrials.gov ID
- NCT07684768
- Acronym / sponsor ID
- QT interval / 170-2023
- Keywords
- Coronary Artery Bypass Grafting, Cardiac Autonomic Neuropathy, Ewing's Cardiovascular Reflex Tests, QT Interval, QTc Interval, General Anesthesia, Cardiac Surgery, Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective isolated coronary artery bypass grafting (CABG) surgery under general anesthesia at a tertiary care university hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous cardiac surgery.
- Emergency CABG.
- Permanent pacemaker implantation.
- Atrial fibrillation or other clinically significant cardiac arrhythmias.
- Bundle branch block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
QT interval variability (ΔQT)
Time frame: From anesthesia induction to 24 hours after surgery.
Corrected QT interval variability (ΔQTc)
Time frame: From anesthesia induction to 24 hours after surgery.
Incidence of QTc prolongation
Time frame: From anesthesia induction to 24 hours after surgery.
Incidence of clinically significant QTc change
Time frame: From anesthesia induction to 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 35472593Tikkanen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiac Autonomic Neuropathy, run by Haseki Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07684768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.