Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the … (NCT03511612) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
France51 participantsStarted 2018-04-24
Plain-language summary
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.
We hypothesize that:
\- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method.
the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients referred with the suspicion of PAD, either because of:
* symptoms in favor of intermittent claudication or more atypical pain when walking, or
* asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following :
* Men \> 60 years or women \> 65 years
* Regular cigarette smoking \>10 years, either current or in the past
* Treated Type-2 diabetes \>5 years or Type-1 diabetes \>20 years
* Treated hypertension
* High blood cholesterol (either total-C \>240 mg/dl or LDL-C \>160 mg/dl) or treated by statins or other lipid-lowering agents
* Documented history of coronary artery disease (history of PCI or CABG, or previous myocardial infarction, or CAD documented by coronary angiography)
* Documented history of ischemic stroke
Exclusion Criteria:
* Patients with revascularized PAD
* Patients with critical limb ischemia or leg/foot ulcers
* Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats
* Patients under dialysis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.