Ankle Brachial IndexNCT04811547
Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients
An observational study of Ankle Brachial Index, run by Shanghai 10th People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Brachial Index
- How many people
- 3,687 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2011to 10 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
None listed.
Who cannot join
- Patients were suffering from mental illness.
- Life expectancy of patients were less than 1 year.
About this study
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
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.
Read the detailed description
The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.
- Conditions
- Ankle Brachial Index
- Keywords
- Atherosclerosis risk, Ankle Brachial Index, Framingham Risk Score, Prediction Model, All-cause Mortality, Cardiac Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from November 2011 to June 2018
Secondary outcomes (1)
New-onset Cardiovascular Events
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).
Measured: from November 2011 to June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start20 Nov 2011
- Primary completion12 Mar 2013
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Brachial IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811547
- Sponsor's protocol ID
- AIRPORTS
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04811547
- Acronym / sponsor ID
- AIRPORTS
- Conditions
- Ankle Brachial Index
- Keywords
- Atherosclerosis risk, Ankle Brachial Index, Framingham Risk Score, Prediction Model, All-cause Mortality, Cardiac Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,687 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 20 Nov 2011 (actual)
- Primary completion
- 12 Mar 2013 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients were suffering from mental illness.
- Life expectancy of patients were less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
New-onset Cardiovascular Events
Time frame: from November 2011 to June 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Brachial Index, run by Shanghai 10th People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Causes mortality and Cardiac mortality (time frame: from November 2011 to June 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.