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NCT Number: NCT04811547

Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients

Framingham Risk Score (FRS) included age, gender, body mass index (BMI), cigarette smoking, blood pressure, total cholesterol (TC), LDL-cholesterol (LDL-C) and diabetes mellitus (DM). Previously, Framingham cohort study and other study has confered patients with medium or high FRS had worse prognosis. However, the score list was tending to over-estimate risk in medium FRS or under-estimate risk in high FRS patients . For this reason, ACC/AHA cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ASCVD) risk assessment and medical decision making.

Meanwhile, the ABI, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (PAD) in the legs. Several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . In addition, ABI aggressively modified risk factors and accelerated the adverse prognosis of ASCVD. However, whether FRS or ABI, were all related to participants and race. And, most studies were from western countries, lack of Asian date, especially aimed at risk prediction model research. Therefore, this research was aimed to validate incorporating ABI and relevant Framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high Framingham risk score (FRS) patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.

Who can participate

Healthy volunteers accepted: No

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

The inclusion criteria:

  • Patients were age older than or equal to 18 years
  • Patients with medium and high Framingham risk score,namely, Framingham Risk Score (FRS) 10%-20%,or FRS > 20%.
  • All participants gave written informed consent to this study, which was approved by the ethics committee of Tongji University.

Exclusion criteria

  • Patients were suffering from mental illness.
  • Life expectancy of patients were less than 1 year.

Treatment and study plan

Primary outcomes

  1. All-Causes mortality and Cardiac mortality

    Time frame: from November 2011 to June 2018

    In this study, the Cardiac death was only cardiac event death. Medical records and death certificates of all patients who had an event were obtained and validated by cardiologist. Death was confirmed from hospital records or by contact with participants and their families. All materials were reviewed independently by five senior physicians of the cohort study to confirm the cause of death.

Secondary outcomes

  1. New-onset Cardiovascular Events

    Time frame: from November 2011 to June 2018

    New-onset Cardiovascular events are composed of cardiac including non-fatal myocardial infarction, unstable angina, and coronary revascularization procedures during follow-up time. Exclusion criteria were stale angina (>6 months), revascularization procedure for CAD ( >6 months) and myocardial infarction( >6 months).

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Adding Ankle Brachial Index to Traditional Framingham Risks Can Improve All-cause Mortality and Cardiac Mortality Prediction in Medium and High Framingham Risk Score Patients: A China Prediction Model

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Mar 23, 2021
Registry last updated
May 12, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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