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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

Tracking Information
First Submitted Date March 13, 2014
First Posted Date March 17, 2014
Last Update Posted Date March 17, 2014
Study Start Date January 2014
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2014)
MACE [ Time Frame: 5-year ]
including death, occurrence of myocardial infarction, and coronary revascularization
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 14, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2014)
Serum level of AGEs [ Time Frame: baseline ]
serum levels of AGEs will be measured and the relationship between clinical outcomes will be analyzed.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Adavanced Glycated Endproducts and Development of CAD
Official Title Study of Serum Level of Advanced Glycated Endproducts and Development of Coronary Atherosclerosis in Patients Undergoing Coronary Angiogram
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Probability Sample
Study Population patients underwent coronary angiogram
Condition
  • Atherosclerosis
  • Inflammation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 14, 2014)
10000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02089360
Other Study ID Numbers RJH20140311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
Study Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date March 2014