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

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04811547

Collaborator

(none)

3,687

Enrollment

65.6

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Brachial Index

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

3687 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Nov 20, 2011

Actual Primary Completion Date :

Mar 12, 2013

Actual Study Completion Date :

May 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

All-Causes mortality and Cardiac mortality [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 Outcome Measures

New-onset Cardiovascular Events [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.