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

NCT ID: NCT04811547

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3687 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-20
• Study Completion Date: 2017-05-10

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.

Detailed Description

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

Conditions

Ankle Brachial Index

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients were age older than or equal to 18 years

2. Patients with medium and high Framingham risk score，namely, Framingham Risk Score (FRS) 10%-20%,or FRS > 20%.

3. All participants gave written informed consent to this study, which was approved by the ethics committee of Tongji University.

Exclusion Criteria

1. Patients were suffering from mental illness.

2. Life expectancy of patients were less than 1 year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

cardiology department of shanghai 10th people's hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AIRPORTS

Identifier Type: -

Identifier Source: org_study_id