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

NCT04811547 | Completed

• 1 other identifier: AIRPORTS
• Study Type: observational
• Target: 3,687
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ankle Brachial Index

Keywords

Atherosclerosis risk; Ankle Brachial Index; Framingham Risk Score; Prediction Model; All-cause Mortality; Cardiac Mortality

Outcome Measures

Primary Outcomes (1)

• All-Causes mortality and Cardiac mortality

  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.

  from November 2011 to June 2018

Secondary Outcomes (1)

• New-onset Cardiovascular Events

  from November 2011 to June 2018

Study Arms (1)

Ankle-Brachial Index value

Valid participants were separated into 0-0.60, 0.61-0.90, 0.91-0.99, and 1.00-1.40 four ABI subgroups.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

There were 3687 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, including 1935 males and 1752 females whose age older than or equal to 18 years. All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from cardiology department and under treatment because of cardiovascular diseases .

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Design

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

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 23, 2021
• Study Start: November 20, 2011
• Primary Completion: March 12, 2013
• Study Completion: May 10, 2017
• Last Updated: May 12, 2021

Record last verified: 2021-03