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Young Toe-Brachial Index Assessment (TBI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by University of British Columbia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02020850
First Posted: December 25, 2013
Last Update Posted: July 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  Purpose
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.

Condition
Diabetes Mellitus Coronary Artery Disease, Vascular Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Determining the Normal Toe-Brachial Index in Young Adults

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Toe-Brachial Index [ Time Frame: Minimum 5 minutes post participant lying supine ]
    The toe and ipsilateral brachial systolic blood pressures will be measured on both side of limbs. The participant should be fully-supported, comfortable, warm with arms and legs at heart level.


Secondary Outcome Measures:
  • Ankle-Brachial Index [ Time Frame: Minimum 5 minutes post participant lying supine ]
    The ankle and ipsilateral brachial systolic blood pressures will be measured on both side of limbs. The participant should be fully-supported, comfortable, warm with arms and legs at heart level.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Toe-Brachial and Ankle-Brachial Index
toe systolic blood pressure, ankle systolic blood pressure, brachial systolic blood pressure test

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the classes of Faculty of Medicine in the University of British Columbia
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020850


Contacts
Contact: York N Hsiang, MB FRCSC 604.876.5882 york.hsiang@vch.ca
Contact: Whitney Quong 604-809-7293 wquong@alumni.ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: York N Hsiang, MB FRCSC    604 876 5882    York.Hsiang@vch.ca   
Contact: Whitney Quong    604 809 7293    wquong@alumni.ubc.ca   
Principal Investigator: York N Hsiang, MB FRCSC         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: York N Hsiang, MB FRCSC UBC, Division of Vascular Surgery and Vancouver General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02020850     History of Changes
Other Study ID Numbers: H13-03144
First Submitted: December 19, 2013
First Posted: December 25, 2013
Last Update Posted: July 4, 2014
Last Verified: July 2014

Keywords provided by University of British Columbia:
Toe-Brachial Index
Ankle-Brachial Index
Systolic blood pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases