Adavanced Glycated Endproducts and Development of CAD (AGENDA)

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ClinicalTrials.gov Identifier: NCT02089360

Recruitment Status : Unknown

Verified March 2014 by Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting

First Posted : March 17, 2014

Last Update Posted : March 17, 2014

Sponsor:

Information provided by (Responsible Party):

Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine

Study Description

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.

Condition or disease
Atherosclerosis Inflammation

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.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	10000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	5 Years
Official Title:	Study of Serum Level of Advanced Glycated Endproducts and Development of Coronary Atherosclerosis in Patients Undergoing Coronary Angiogram
Study Start Date :	January 2014
Estimated Primary Completion Date :	January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

MACE [ Time Frame: 5-year ]
including death, occurrence of myocardial infarction, and coronary revascularization

Secondary Outcome Measures :

progression in coronary atherosclerosis [ Time Frame: 5-year ]
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.

Other Outcome Measures:

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

Biospecimen Retention: Samples With DNA

Blood sample is taken for all patients underwent coronary angiogram after getting informed consent, and stored in requested condition, for measuring serum levels of different kinds of factors.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients underwent coronary angiogram

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089360

Contacts

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Contact: Qi Zhang, PhD	86-21-64370045 ext 665380	rjheart@gmail.com
Contact: Wei Feng Shen, PhD	86-21-64370045 ext 665215	rjshenweifeng@gmail.com

Locations

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China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Recruiting
Shanghai, Shanghai, China, 200025
Contact: Lin Lu, PhD 86-21-64370045 ext 610910 rjlulin1965@163.com
Principal Investigator: Lin Lu, PhD

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang CD, Shen Y, Lu L, Yang ZK, Hu J, Zhang RY, Shen WF, Ding FH, Wang XQ. Visit-to-visit HbA(1c) 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.

Yang CD, Shen Y, Ding FH, Yang ZK, Hu J, Shen WF, Zhang RY, Lu L, Wang XQ. Visit-to-visit fasting plasma glucose variability is associated with left ventricular adverse remodeling in diabetic patients with STEMI. Cardiovasc Diabetol. 2020 Sep 2;19(1):131. doi: 10.1186/s12933-020-01112-6.

Yang CD, Shen Y, Lu L, Ding FH, Yang ZK, Zhang RY, Shen WF, Jin W, Wang XQ. Insulin resistance and dysglycemia are associated with left ventricular remodeling after myocardial infarction in non-diabetic patients. Cardiovasc Diabetol. 2019 Aug 7;18(1):100. doi: 10.1186/s12933-019-0904-3.

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Responsible Party:	Zhang Qi, MD, Director, Cardiac Catheterization Lab, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT02089360
Other Study ID Numbers:	RJH20140311
First Posted:	March 17, 2014 Key Record Dates
Last Update Posted:	March 17, 2014
Last Verified:	March 2014

Keywords provided by Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine:


Advanced glycation end product coronary atherosclerosis inflammation outcome

Additional relevant MeSH terms:

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Atherosclerosis Inflammation Pathologic Processes Arteriosclerosis	Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases

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