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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374655
• Other study ID #: blank
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2023
• Source: Beijing Anzhen Hospital
• Contact: Kun Hua
• Phone: +8615810111206
• Email: huakun0310[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: August 31, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Preoperative blood glucose control
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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Kun Hua	Beijing Huaxin Hospital, Peking University International Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All-cause Mortality	All-cause mortality identified during one-year follow-up	one year post operative