Diabetes MellitusCATHEDRALNCT05134129
Correlation Between Targeted HbA1c Values and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After PCI
An observational study of Diabetes Mellitus and Percutaneous Coronary Intervention, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Percutaneous Coronary Intervention
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 1. Age ≥ 18, male or female;
- 2. all patients with diabetes combined with PCI operation;
Who cannot join
- 1. Less than 18 years old
- 2. Pregnancy
- 3. Patients with preoperative glycosylated hemoglobin index deficiency
- 4. Chronic maintenance hemodialysis patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology,Shanghai Tenth People's Hospital
Shanghai, 200072
Yan Cang, PhD, 18917682207, cang_gu@aliyun.com
Yawei Xu, PhD, xuyawei@tongji.edu.cn
About this study
Official title: Correlation Between Targeted Hemoglobin A1C Levels and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After Coronary Intervention
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.
Read the 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.
- Keywords
- Glycated Hemoglobin, Percutaneous Coronary Intervention, Metabolomics, Diabetes Mellitus, Cardiovascular Risk
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary revascularization
Coronary revascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.
Measured: 3 years
All cause mortality
which refers to the total death caused by various causes in a certain period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 Apr 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yan Cang, MD, Principal investigator, Department of Cardiology, Shanghai Tenth People's HospitalZheng Liu, pHD, Principal investigator, Department of Cardiology, Shanghai Tenth People's HospitalZhicai Wang, MD, Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134129
- Sponsor's protocol ID
- CATHEDRAL
- Acronym
- CATHEDRAL
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Targeted Hemoglobin A1C Levels and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After Coronary Intervention
- ClinicalTrials.gov ID
- NCT05134129
- Acronym / sponsor ID
- CATHEDRAL / CATHEDRAL
- Keywords
- Glycated Hemoglobin, Percutaneous Coronary Intervention, Metabolomics, Diabetes Mellitus, Cardiovascular Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 1. Age ≥ 18, male or female;
- 2. all patients with diabetes combined with PCI operation;
Key exclusion criteria (4 listed)
- 1. Less than 18 years old
- 2. Pregnancy
- 3. Patients with preoperative glycosylated hemoglobin index deficiency
- 4. Chronic maintenance hemodialysis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
All cause mortality
Time frame: 3 years
which refers to the total death caused by various causes in a certain period.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Percutaneous Coronary Intervention, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Cang, MD (18917682207, cang_gu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary revascularization (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.