NCT03616418

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2.6 years

First QC Date

July 31, 2018

Last Update Submit

December 8, 2021

Conditions

Keywords

ankle brachial indexcardiovascular diseaserisk factorsFramingham Cardiovascular Risk Scoreuric acidsurvival analysis

Outcome Measures

Primary Outcomes (1)

  • all cause mortality and cardiovascular mortality

    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.

    From August 2018 to August 2020

Interventions

Also known as: According to the international guidelines, we treated patients who suffered from different disease.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiology department of shanghai 10th people's hospital

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

January 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share