Clinical trial NCT03616418: Ankle Brachial Index Combined With Serum Uric Acid Levels Improve Prediction All Cause Mortality and Cardiovascular Mortality in the Elderly Chinese Population
Official title: Ankle Brachial Index Combined With Serum Uric Acid Levels Improve Prediction All Cause Mortality and Cardiovascular Mortality in the Elderly Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Brachial Index
Keywords: ankle brachial index
cardiovascular disease
risk factors
Framingham Cardiovascular Risk Score
uric acid
survival analysis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 3026
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects aged over 65 years old, living in communities located in the Shanghai, will be invited to participate in the present study, if they are willing to give their written informed consents.

Brief summary: Peripheral arterial disease (PAD) is a common clinical manifestation of the systemic atherosclerotic process, and the ankle brachial index (ABI) is an ideal tool to diagnose PAD. The association between high serum uric acid levels (SUA) 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. It has also been confirmed by clinical studies. Currently, there have been few long term follow up studies focused on the whether serum uric acid levels combined with ankle brachial index can improve prediction all cause mortality and cardiovascular mortality,especially in China population.Therefore, the aim of this study was to elucidate whether ABIcombined with SUA can improve prediction all cause mortality and cardiovascular mortality in the elderly China population independently of the traditional Framingham Risk Score.

Detailed description: This study is a prospective community-based cohort study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and measure ABI,SUA,asymptomatic target organ damage, for mortality and cardiovascular diseases. All population were separated into ABI ≤0.50，0.51 \<ABI ≤0.9，and 0.91 \<ABI≤1.40 three groups according to the ABI. ABI ≤0.9 was selected as cut point for the definition of PAD. Factors related to CVD and all-cause mortality, major adverse cardiac events (MACE) during follow-up was observed by multivariate Cox regression analysis and log rank test. Potential confounding variables with P \<0.10 were adjusted for multivariate analysis.

Eligibility criteria: Inclusion Criteria:

1. age≥65 years old
2. Shanghai residents
3. Sign informed consent

Exclusion Criteria:

1. serious heart disease (NYHA\>IV) or end stage renal disease (CKD \> 4)
2. cancer and life expectancy was less than 5 years
3. Severe congestive heart failure and Severe renal failure patients
4. Participants had other diseases that required withdrawal from the clinical trial
5. Patients are reluctant to participate in clinical research
6. The patient violated the experimental protocol
7. Clinical diagnosis of Alzheimer's Disease

Primary outcomes:
measure: all cause mortality and cardiovascular mortality
timeFrame: From August 2018 to August 2020
Secondary outcomes:
Other outcomes:
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