Cardiovascular Surgical Procedures, Major Adverse Cardiovascular Events (MACE)
Conditions
Keywords
Compound Vitamin B, Cardiovascular Surgery, Major Adverse Cardiovascular Events
Brief summary
This study is a multicenter, randomized controlled, double-blind, placebo-controlled parallel trial designed to evaluate the effect of perioperative supplementation with Compound Vitamin B on patients undergoing cardiovascular surgery. A total of 1,000 patients aged 18-80 years who are scheduled to receive cardiovascular surgeries such as coronary artery bypass grafting (CABG) and valve replacement will be enrolled. They will be randomly assigned at a 1:1 ratio to either the experimental group (perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery) or the control group (oral placebo), with both groups receiving standardized perioperative treatment.
Interventions
DRUGCompound Vitamin B tablet
perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
DRUGControl
perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery
Sponsors
Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
The First Affiliated Hospital of Guangzhou Medical University
The Affiliated Hospital of Qingdao University
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-80 years, regardless of gender; * Scheduled to receive cardiovascular surgery at the research center, including coronary artery bypass grafting (CABG), cardiac valve replacement/repair, and great vessel surgery; * Preoperative assessment indicates that the patient is expected to complete the 6-month postoperative follow-up; * The patient or their authorized agent signs a written informed consent form.
Exclusion criteria
* Regular supplementation with Compound Vitamin B (daily dose ≥ 1.5 times the recommended dietary allowance) or separate supplementation with folic acid, vitamin B6, or B12 within 3 months before surgery; * Severe hepatic or renal insufficiency (liver function: ALT/AST \> 3 times the upper limit of normal, or total bilirubin \> 2 times the upper limit of normal; renal function: serum creatinine \> 265 μmol/L, or requiring long-term dialysis treatment); * Malignant tumors, severe hematological diseases (e.g., megaloblastic anemia, aplastic anemia), severe malnutrition (albumin \< 25 g/L); * History of allergy to Compound Vitamin B preparations or placebo components; Pregnant women, lactating women, or those planning to become pregnant during the study period; * Currently participating in other interventional clinical trials; * Moderate to severe cognitive impairment without a fixed caregiver, unable to cooperate with treatment and follow-up; * Preoperatively diagnosed with severe infection, septicemia, or septic shock.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the incidence of MACE | within 6 months after surgery between the two groups | MACE is defined as a composite endpoint, including: cardiac death, non-fatal myocardial infarction (postoperative troponin peak \> 10 times the upper limit of normal accompanied by chest pain and dynamic changes in electrocardiogram), ischemic stroke (new-onset neurological deficits after surgery confirmed by cranial CT/MRI), severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block requiring implantation of a temporary/permanent pacemaker), and readmission due to cardiac causes. |
Countries
China
Contacts
CONTACTHong Liu, MD
CONTACTGuo-laing Fan, MD
STUDY_CHAIRGuo-liang Fan
Shanghai East Hospital
Outcome results
None listed