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

NCT05374655 | Unknown

• 1 other identifier: blank
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

Cardiac Surgery; Atrial Fibrillation; Glycosylated Hemoglobin; Cox-Maze IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of atrial fibrillation recurrence

  6 months post operative

• All-cause Mortality

  one year post operative

Study Arms (2)

Preoperative blood glucose control

EXPERIMENTAL

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

Preoperative blood glucose uncontrol

NO INTERVENTION

Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly

Interventions

Preoperative blood glucose control OTHER

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.

Preoperative blood glucose control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kun Hua: lead
• Peking University People's Hospital: collaborator
• Peking University International Hospital: collaborator
• Beijing Huaxin Hospital: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kun Hua

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Kun Hua

CONTACT

+8615810111206; huakun0310@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Surgeon

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: May 15, 2022
• Primary Completion: June 7, 2024
• Study Completion: August 31, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

CN (1)