Adavanced Glycated Endproducts and Development of CAD

Inflammation Clinical Trial

— AGENDA  

Official title:

Study of Serum Level of Advanced Glycated Endproducts and Development of Coronary Atherosclerosis in Patients Undergoing Coronary Angiogram

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02089360
• Other study ID #: RJH20140311
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 14, 2014
• Start date: January 2014

Study information

• Verified date: March 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Qi Zhang, PhD
• Phone: 86-21-64370045
• Email: rjheart[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum level of AGEs	serum levels of AGEs will be measured and the relationship between clinical outcomes will be analyzed.	baseline	No
Primary	MACE	including death, occurrence of myocardial infarction, and coronary revascularization	5-year	No
Secondary	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	No