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Adavanced Glycated Endproducts and Development of CAD (AGENDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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




Primary Outcome Measures :
  1. MACE [ Time Frame: 5-year ]
    including death, occurrence of myocardial infarction, and coronary revascularization


Secondary Outcome Measures :
  1. 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:
  1. 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.


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

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
Additional Information:

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