Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811547
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2021-03-13
Brief Title:
Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients
Sponsor:
Shanghai 10th Peoples Hospital
Organization:
Shanghai 10th Peoples Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ACCAHA 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None