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History of Changes for Study: NCT05134129
Correlation Between Targeted HbA1c Values and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After PCI (CATHEDRAL)
Latest version (submitted November 22, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 22, 2021 None (earliest Version on record)
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Study NCT05134129
Submitted Date:  November 22, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: CATHEDRAL
Brief Title: Correlation Between Targeted HbA1c Values and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After PCI (CATHEDRAL)
Official Title: Correlation Between Targeted Hemoglobin A1C Levels and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After Coronary Intervention
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2021
Overall Status: Recruiting
Study Start: April 25, 2021
Primary Completion: September 1, 2024 [Anticipated]
Study Completion: September 1, 2024 [Anticipated]
First Submitted: August 10, 2021
First Submitted that
Met QC Criteria:
November 22, 2021
First Posted: November 24, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
November 22, 2021
Last Update Posted: November 24, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Shanghai 10th People's Hospital
Responsible Party: Principal Investigator
Investigator: Ya-Wei Xu
Official Title: Chief Physician
Affiliation: Shanghai 10th People's Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Detailed Description: 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.
Open or close this module Conditions
Conditions: Diabetes Mellitus
Percutaneous Coronary Intervention
Keywords: Glycated Hemoglobin
Percutaneous Coronary Intervention
Metabolomics
Diabetes Mellitus
Cardiovascular Risk
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Blood samples were taken for metabolomics study.
Enrollment: 1500 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Coronary revascularization
[ Time Frame: 3 years ]

Coronary revascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.
2. All cause mortality
[ Time Frame: 3 years ]

which refers to the total death caused by various causes in a certain period.
3. Cardiac mortality
[ Time Frame: 3 years ]

Cardiac death refers to the death caused by serious cardiac dysfunction or failure caused by heart disease or injury in a certain period.
4. Differential polar compound
[ Time Frame: 3 years ]

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.
5. Differential lipid compounds
[ Time Frame: 3 years ]

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.
Open or close this module Eligibility
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.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
Criteria:

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

Open or close this module Contacts/Locations
Central Contact Person: Yan Cang, MD
Telephone: 18917682207
Email: cang_gu@aliyun.com
Central Contact Backup: Zhicai Wang, MD
Telephone: 19154087651
Email: 19154087651@163.com
Study Officials: Yan Cang, MD
Principal Investigator
Department of Cardiology, Shanghai Tenth People's Hospital
Zheng Liu, pHD
Principal Investigator
Department of Cardiology, Shanghai Tenth People's Hospital
Zhicai Wang, MD
Principal Investigator
Department of Cardiology, Shanghai Tenth People's Hospital
Locations: China
Department of Cardiology,Shanghai Tenth People's Hospital
[Recruiting]
Shanghai, China, 200072
Contact:Contact: Yan Cang, PhD 18917682207 cang_gu@aliyun.com
Contact:Contact: Yawei Xu, PhD xuyawei@tongji.edu.cn
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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