Young Toe-Brachial Index Assessment (TBI)
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|ClinicalTrials.gov Identifier: NCT02020850|
Recruitment Status : Unknown
Verified July 2014 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : December 25, 2013
Last Update Posted : July 4, 2014
|Condition or disease|
|Diabetes Mellitus Coronary Artery Disease, Vascular Diseases|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Determining the Normal Toe-Brachial Index in Young Adults|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
Toe-Brachial and Ankle-Brachial Index
toe systolic blood pressure, ankle systolic blood pressure, brachial systolic blood pressure test
- 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.
- 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.
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
|Contact: York N Hsiang, MB FRCSCfirstname.lastname@example.org|
|Contact: Whitney Quongemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: York N Hsiang, MB FRCSC|
|Principal Investigator:||York N Hsiang, MB FRCSC||UBC, Division of Vascular Surgery and Vancouver General Hospital|