Clinical trial NCT03616769: A Prospective Cohort Study of China Serum Uric Acid Levels
Official title: Relationship of Serum Uric Acid Levels With All Cause Mortality and Cardiovascular Mortality in Multiple Classical Framingham Risk Factors Patients After a Six-year Follow-up: a China Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uric Acid Serum
Keywords: Uric Acid Serum; Prospective;
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 3535
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There were 3,535 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, 76 of whom had missing follow-up data. Thus,the study sample actually comprised 3,047 valid participants whose age older than or equal to 35 years.All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from the cardiology department and under treatment because of cardiovascular diseases .

Brief summary: Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. But debates still existed for hyperuricemia and hypouricemia as an independent role,especially after controlling other traditional atherosclerotic risk.The aim of this study was, firstly, to verify the association between hyperuricemia and cardiovascular diseases,secondly,to assess whether hypouricemia was an independent risk factor impact for cardiovascular disea.

Detailed description: The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011. The eligible participants were followed up from November 2011 to June 2018 (mean follow-up months 68.71±11.35). During the followed-up time, 67 patients had missing data and 56 had no compliance. Thus, the study sample actually comprised 3,047 valid participants (1536 men, 1511 women) whose age older than or equal to 35 years (mean age 60.2±10.4 years) were followed up. A total of hospitalized patients were consecutively enrolled from cardiology department of Beijing and Shanghai. All subjects are under treatment because of cardiovascular diseases.

Eligibility criteria: Inclusion Criteria:

age older than or equal to 35 years with multiple classical Framingham risk factors patients.

Exclusion Criteria:

Severe congestive heart failure and Severe renal failure patients.Severe congestive heart failure was defined that above or equal to cardiac functional classify 3 formulated by New York Heart Association (NYHA). Severe renal failure was defined as an estimated glomerular filtration rate \<60 ml/ min/1.73m2.

Primary outcomes:
measure: all cause mortality and cardiovascular mortality
timeFrame: rom November 2011 to June 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cang Y, Xu S, Zhang J, Ju J, Chen Z, Wang K, Li J, Xu Y. Serum Uric Acid Revealed a U-Shaped Relationship With All-Cause Mortality and Cardiovascular Mortality in High Atherosclerosis Risk Patients: The ASSURE Study. Front Cardiovasc Med. 2021 May 24;8:641513. doi: 10.3389/fcvm.2021.641513. eCollection 2021.