Young Toe-Brachial Index Assessment

NCT ID: NCT02020850

Last Updated: 2014-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average value we measured in normal individuals is about 1.0, furthermore, we can not find out the reference of TBI that is currently being used. The purpose of this study is to determine the more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants will be required to fill out a demographic questionnaire before the blood pressures test. All participants will have their toe, ankle and brachial systolic blood pressure measurements to obtain the TBI and ABI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All participants will fill out a demographic questionnaire that includes:

* Race, gender, age
* Height and weight
* Perceived stress level (potentially measured using Cohen's Perceived Stress scale(PSS))
* Activity level, with description hours per week, cardio versus non-cardio, and intensity (mild, moderate, intense)
* Smoking history, alcohol consumption, caffeine intake, and drug use (recreational, medicine - over - the - counter and prescription, including birth control pills)
* Hand dominance, and leg dominance
* Past medical history - with emphasis on cardiovascular disease (hypertension, cancer, coronary heart disease, diabetes mellitus, high cholesterol, coagulopathies, previous thromboses) as well as renal, adrenal, and thyroid disorders, Raynaud's phenomenon
* Family medical history (cancer, coronary heart disease, diabetes mellitus, high cholesterol)

Participants with known existing diabetes, coronary artery disease, or a history of vascular disease will be included in the study; nevertheless, their results may be analyzed in a separate cohort for comparison against those undiagnosed with the aforementioned condition.

The TBI (Toe - Brachial Index) will be measured by the following procedure.

* The assessment time and room temperature will be recorded
* The participant should lay supine for a minimum of five minutes in a warm and comfortable room
* Select the appropriate cuff for each upper arm and each large toe and separately placed them around the arm and large toe.
* The blood pressure measurements will be performed with photo plethysmography (PPS) and chart recorder. The phototransducer is connected to the PPS, and the digit cuff is connected to an aneroid sphygmomanometer.
* The toe and ipsilateral arm systolic blood pressures will be measured up to three times for accuracy.
* The TBI will be calculated by dividing the averaged toe systolic blood pressure, by the averaged brachial systolic blood pressure.

The ABI (Ankle - Brachial Index) will be measured by the following procedure.

* The blood pressure cuff will be placed proximal to the malleoli and ultrasound gel cover the skin overlying the dorsalis pedis and posterior tibial arteries in the foot.
* The dorsalis pedis and posterior tibial arteries blood pressure will be measured by using hand-held Doppler probe.
* The ankle systolic blood pressure will be taken as the higher pressure of the 2 arteries at the ankle.
* The ABI will be calculated by dividing the ankle systolic blood pressure, by the averaged brachial systolic blood pressure.

The brachial, toe and ankle blood pressures will be measured on the opposite limbs, and the TBI and ABI will be calculated following the protocol outlined above.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Coronary Artery Disease, Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Toe-Brachial and Ankle-Brachial Index

toe systolic blood pressure, ankle systolic blood pressure, brachial systolic blood pressure test

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All students from the University of British Columbia, Faculty of Medicine graduating class of 2017

Exclusion Criteria

* Students who declined to participate in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

York N Hsiang, MB FRCSC

Role: PRINCIPAL_INVESTIGATOR

UBC, Division of Vascular Surgery and Vancouver General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

York N Hsiang, MB FRCSC

Role: CONTACT

604.876.5882

Whitney Quong

Role: CONTACT

604-809-7293

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

York N Hsiang, MB FRCSC

Role: primary

604 876 5882

Whitney Quong

Role: backup

604 809 7293

References

Explore related publications, articles, or registry entries linked to this study.

Quong WL, Fung AT, Yu RY, Hsiang YN. Reassessing the normal toe-brachial index in young healthy adults. J Vasc Surg. 2016 Mar;63(3):652-6. doi: 10.1016/j.jvs.2015.09.019.

Reference Type DERIVED
PMID: 26916582 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H13-03144

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomechanical Analysis of Gait
NCT07140159 COMPLETED