Adavanced Glycated Endproducts and Development of CAD | NCT02089360

Studies
Adavanced Glycated Endproducts and Development of CAD

NCT02089360

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Mar 17, 2014Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Atherosclerosis
Inflammation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 13, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2014

Last Update Posted Date

Mar 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Qi, MD, Director, Cardiac Catheterization Lab, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Blood sample is prospectively taken from consecutive patients underwent coronary angiogram in our center, after getting informed consent from the patients. Serum level of advanced glycation end products (AGEs) was measured and the clinical features of patients (including angiographic results) were entered into our database. Clinical follow-up was performed for all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further intervention will be adjusted according to the results,including clinical and basic research in lab.

Detailed Description

Serum levels of HMGB1, HMGB2, ADAM10, etc. will be measured in lab and animal studies will be designed to intervene the adverse interaction between abnormal serum concentration of AGEs, etc. and worse clinical results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	including death, occurrence of myocardial infarction, and coronary revascularization	5-year

Secondary Outcomes

Measure	Description	Time Frame
progression in coronary atherosclerosis	repeated coronary angiogram in patients with symptom aggravation or occurrence of myocardial infarction, to evaluate the progression of coronary lesions, comparing to the baseline results.	5-year

Other Outcomes

Measure	Description	Time Frame
Serum level of AGEs	serum levels of AGEs will be measured and the relationship between clinical outcomes will be analyzed.	baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients underwent coronary angiogram for suspected coronary artery disease and potential percutaneous coronary intervention

Exclusion Criteria:

patients underwent coronary angiogram for other reasons, including pre-surgery examination
patients with severe co-morbidity, and life expectancy less than one-year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients underwent coronary angiogram

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Zhang, PhD	Contact	86-21-64370045	665380	rjheart@gmail.com
Wei Feng Shen, PhD	Contact	86-21-64370045	665215	rjshenweifeng@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200025	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32887588	Derived	Yang CD, Shen Y, Lu L, Yang ZK, Hu J, Zhang RY, Shen WF, Ding FH, Wang XQ. Visit-to-visit HbA1c variability is associated with in-stent restenosis in patients with type 2 diabetes after percutaneous coronary intervention. Cardiovasc Diabetol. 2020 Sep 4;19(1):133. doi: 10.1186/s12933-020-01111-7.
32878604	Derived

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D050197	Atherosclerosis
D007249	Inflammation