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NCT Number: NCT03616418

Ankle Brachial Index Combined With Serum Uric Acid Levels Improve Prediction All Cause Mortality and Cardiovascular Mortality in the Elderly Chinese Population

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age≥65 years old
  • Shanghai residents
  • Sign informed consent

Exclusion criteria

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

Treatment and study plan

antiplatelet drugs;statins;antihypertensive drugs

Drug

Other names: According to the international guidelines, we treated patients who suffered from different disease.

Primary outcomes

  1. all cause mortality and cardiovascular mortality

    Time frame: From August 2018 to August 2020

    Cardiovascular events definitions: Hospitalized myocardial infarction was classified as definite or probable based on chest pain symptoms, cardiac enzyme levels, and electrocardiographic findings, or angioplasty28. Coronary heart disease was determined to be present if there was (1) electrocardiographic (ECG) evidence of a prior myocardial infarction, (2) prior coronary artery bypass surgery or angioplasty, (3) Coronary angiography show coronary heart disease, (4) have symptoms of angina and ECG revealed myocardial ischemia performance or laboratory tests showed cardiac enzymes increased and exclude other types of disease, (5) a self-reported history of a physician-diagnosed heart attack 29. CHD death was classified "definite" based on chest pain symptoms, hospital records, and medical history.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Acronym: abilities

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Aug 6, 2018
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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