Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Surgery
• Interventions: Other: Preoperative blood glucose control

• Registration Number: NCT05374655
• Lead Sponsor: Kun Hua

Brief Summary

In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-13
• Study Start: 2022-05-15
• Study First Posted: 2022-05-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20
• Primary Completion: 2024-06-07
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Age ≥18 years
• Elective cardiac surgery
• A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment
• Preoperative combination of persistent or long-term persistent atrial fibrillation

Exclusion Criteria

• Emergency surgery or limited-term surgery
• Previous cardiac surgery
• Left atrial diameter > 65 mm
• Serum creatine > 1.8 mg/dL
• Previous severe liver disease
• Pregnant or planning to become pregnant
• Have a malignant tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative blood glucose control	Preoperative blood glucose control	Under the guidance of endocrinologists, the patient's hypoglycemic strategy is formulated, follow-up guidance is guided by the patient to take the drug, the HbA1c level is reviewed after 6 weeks, the preoperative HbA1c \< 7.5% is performed surgically, and if it is still above the standard, the hypoglycemic therapy is continued, during which the patient is administered according to the corresponding heart disease type.

Primary Outcome Measures

Name	Time	Method
Rate of atrial fibrillation recurrence	one year post operative	Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	one year post operative	All-cause mortality identified during one-year follow-up
Rate of atrial fibrillation recurrence	6 months post operative	Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China