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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Randomized Controlled Clinical Study of Preoperative Glycosylated Hemoglobin Control Strategies on the Effectiveness of Cox-Maze IV Procedure for Atrial Fibrillation During Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: Preoperative blood glucose control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative blood glucose control<br>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. | Other: Preoperative blood glucose control<br>* Patients included in this group, under the guidance of endocrinologists, develop hypoglycemic strategies for patients, follow up and guide patients to take medication, review HbA1c levels after 6 weeks, perform surgical treatment if they meet preoperative HbA1c<7.5%, continue hypoglycemic therapy if still above standards, and administer drugs according to the corresponding type of heart disease during this period.<br>|
| No Intervention: Preoperative blood glucose uncontrol<br>Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of atrial fibrillation recurrence | Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds | one year post operative | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Atrial Fibrillation, Glycosylated Hemoglobin, Cox-Maze IV