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

NCT ID: NCT05134129

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-25

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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This is a longitudinal cohort study including retrospective study, prospective study and nested case-control study.The first cross-sectional survey was conducted in 2021.

Conditions

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Diabetes Mellitus Percutaneous Coronary Intervention

Keywords

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Glycated Hemoglobin Percutaneous Coronary Intervention Metabolomics Diabetes Mellitus Cardiovascular Risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- 1. Age ≥ 18, male or female;

2\. all patients with diabetes combined with PCI operation;

Exclusion Criteria

* 1\. Less than 18 years old

2\. Pregnancy

3\. Patients with preoperative glycosylated hemoglobin index deficiency

4\. Chronic maintenance hemodialysis patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Cang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Zheng Liu, pHD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Zhicai Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Locations

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Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Cang, MD

Role: CONTACT

Phone: 18917682207

Email: [email protected]

Zhicai Wang, MD

Role: CONTACT

Phone: 19154087651

Email: [email protected]

Facility Contacts

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Yan Cang, PhD

Role: primary

Yawei Xu, PhD

Role: backup

Other Identifiers

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CATHEDRAL

Identifier Type: -

Identifier Source: org_study_id