Status:
UNKNOWN
Renal Sympathetic Modification in Patients With Metabolic Syndrome
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Collaborating Sponsors:
Jiangsu Provincial People's Hospital
Chongqing Medical University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with metabolic syndrome, and evaluat...
Detailed Description
Metabolic syndrome is combination risk factors of serial cardiovascular and metabolic disease, included central obesity, insulin resistance, dyslipidemia, and hypertension. Basic studies suggested tha...
Eligibility Criteria
Inclusion
- ≥ 18 years old, and ≤ 75 years old of age
- abnormal metabolism: 1) body mass index (BMI) of ≥ 25 kg/m2; 2) total triglyceride (TG) of ≥ 1.70mmol/l (150mg/dl); 3) high density lipoprotein- cholesterol (HDL-C) of male \<0.91mmol/l (35mg/dl), and of female \<1.01mmol/l (39mg/dl); 4)fasting blood glucose 6.1mmol/l (110mg/dl), or glucose tolerance test of 2 hours ≥ 7.8 mmol/l (140mg/dl); 5), or history of diabetes mellitus
- estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
- is competent and willing to provide written, informed consent to participate in this clinical study
Exclusion
- secondary hypertension
- type 1 diabetes mellitus
- estimated glomerular filtration rate (eGFR) of \< 45mL/min
- has the history of renal restenosis or renal stents implantation
- has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
- patients with sick sinus syndrome
- pregnant women
- mental disorders
- patients that have allergy to contrast agent
- patients that do not go with follow-up
- others such as researcher considers it is not appropriate to be included into the study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01417247
Start Date
August 1 2011
End Date
June 1 2020
Last Update
March 19 2019
Active Locations (1)
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1
2ndChongqingMU
Chongqing, Chongqing Municipality, China, 400010