Correlation Between Targeted HbA1c Values and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After PCI

NCT05134129 | Unknown

• 1 other identifier: CATHEDRAL
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a leading social and economic burden in the world. It is the main reason of macrovascular disease incidence and mortality. Prospective studies have demonstrated that high glycosylated hemoglobin (HbA1C) levels are associated with an increased risk of cardiovascular events in a population of diabetic patients without a history of coronary artery disease. Further, the predictive value of high preprocedural glycemia levels has been reported in diabetic patients undergoing percutaneous coronary intervention (PCI). The aim of the present study was to assess the predictive value of preprocedural HbA1C levels for cardiovascular complications in a large population of diabetic patients undergoing PCI with stent implantation. Glycosylated hemoglobin (HbA1c) reflects the average blood sugar level in the past 2-3 months. As glycosylated hemoglobin has been clinically tested and standardized internationally, increasing evidence is recommended for routine monitoring in diabetes care. The American Diabetes Association (ADA) suggested that in the treatment of diabetes, blood sugar control should control HbA1c level below 6.5%. Although，there is evidence that controlling blood glucose can reduce the incidence of microvascular complications, in the past three trials, intensive glycemic control did not significantly reduce adverse CV events in patients with onger duration of diabetes.Therefore, most primary and secondary prevention guidelines recommend HbA1c below 6.5% or 7% to prevent adverse cardiovascular outcomes in patients with diabetes mellitus. The optimal target level of glycosylated hemoglobin is still hotly debated. In addition, there is still lack of evidence for the level of HbA1c in patients with major vascular disease history in secondary prevention of recurrence cardiovascular events. Therefore, to explore and determine the optimal level of blood glucose control is the focus of controversy in preventing recurrence cardiovascular events in diabetic patients. Investigator will combine epidemiology and metabolomics to study the effect of glycosylated hemoglobin on secondary cardiovascular events, and further determine whether to strengthen hypoglycemic treatment after PCI.

Conditions

Diabetes Mellitus; Percutaneous Coronary Intervention

Keywords

Glycated Hemoglobin; Percutaneous Coronary Intervention; Metabolomics; Diabetes Mellitus; Cardiovascular Risk

Outcome Measures

Primary Outcomes (5)

• Coronary revascularization

  Coronary revascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.

  3 years

• All cause mortality

  which refers to the total death caused by various causes in a certain period.

  3 years

• Cardiac mortality

  Cardiac death refers to the death caused by serious cardiac dysfunction or failure caused by heart disease or injury in a certain period.

  3 years

• Differential polar compound

  Metabonomic analysis uses non targeted detection methods to detect polar compounds in blood. The characteristic peaks of detectable substances were detected by chromatographic Series platform, and then these characteristic peaks were compared with the standard library containing more than 8000 metabolites, annotated the compounds, and screened out the different metabolites between groups.

  3 years

• Differential lipid compounds

  Metabonomic analysis uses non targeted detection methods to detect lipid compounds in blood. The characteristic peaks of detectable substances were detected by chromatographic Series platform, and then these characteristic peaks were compared with the standard library containing more than 8000 metabolites, annotated the compounds, and screened out the different metabolites between groups.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Demographic data, cardiovascular examinations and laboratory parameters were collected from 1500 hospitalized diabetic patients with PCI. Patients younger than 18 years old, pregnant, preoperative HbA1c deletion and chronic maintenance hemodialysis were excluded. According to ADA and AHA guidelines and predetermined glycosylated hemoglobin values, based on clinical relevance, especially glycosylated hemoglobin \< 6.5%, 6.5% ≤ glycosylated hemoglobin ≤ 7.0%, glycosylated hemoglobin \> 7.0%, and statistical end events including patients with more than or equal to two PCI enents, patients with all-cause motality and cardiac motality.Through prospective cohort study and nested case-control study,analysis related risk factors and metabolomics molecular differences between revascularization patients and non-revascularization patients.The instrument platforms of gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) are used to metabonomic analysis.

You may qualify if:

• \- 1. Age ≥ 18, male or female;
• \. all patients with diabetes combined with PCI operation;

You may not qualify if:

• \. Less than 18 years old
• \. Pregnancy
• \. Patients with preoperative glycosylated hemoglobin index deficiency
• \. Chronic maintenance hemodialysis patients

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, 200072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were taken for metabolomics study.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yan Cang, MD

  Department of Cardiology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

• Zheng Liu, pHD

  Department of Cardiology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhicai Wang, MD

  Department of Cardiology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Cang, MD

CONTACT

18917682207; cang_gu@aliyun.com

Zhicai Wang, MD

CONTACT

19154087651; 19154087651@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: November 24, 2021
• Study Start: April 25, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)