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CPC leads the industry in standardizing the ABI assessment at clinical trials sites through our unique quality intervention. The ABI is the ratio of the systolic blood pressure in the ankle to the arm, which is commonly used to make the diagnosis of peripheral arterial disease (PAD).
When the ratio is less than 0.90 this is diagnostic of peripheral arterial disease.
It can be useful in identifying appropriate patients for PAD clinical trials. It is also frequently used as an
endpoint to detect improved blood flow and pressure to the lower extremities. The
ABI is not an easy measurement to make reliably with consistent results. CPC has developed
interventions that provide a consistent method of obtaining ABI measurements, allowing this
measurement to be used as a more reliable and reproducible diagnostic tool and endpoint in
clinical trials.
Factors affecting the variability of the ABI:
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Patient activity prior to testing
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Size and placement of the blood pressure cuff
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Utilization of a stethoscope vs. a Doppler
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Slipping off the artery during or after cuff inflation
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Improper placement of the Doppler probe
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Not repeating measurements
These, and other factors effecting variability, can be controlled in a
clinical research setting with thorough training and oversight.
CPC Interventions:
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Site Endpoint Evaluation Visit, which includes: 1) assessment of the sites’ equipment for
appropriateness for the protocol, 2) evaluation of the techniques utilized by each staff member who
will administer the ABI, 3) source document review to evaluate adherence to the protocol and CPC’s
data collection guidelines, 4) A detailed report to the site noting all issues at their site and specific
recommendations for improving the procedure at their site
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A reference tool for sites to use during the ABI procedure
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Hands on training to the site staff during an Investigator Meeting
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Development of source documents specific to ABI and the calculations to determine ABI
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Weekly review at Endpoint Evaluation Committee meetings of issues identified during
SEEVs; recommendations for corrective actions are forthcoming from this meeting
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Receiving phone calls or other inquiries from sites about data collection methods
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Sponsor Training on ABI
CPC offers quality assurance of ABI measurements as described as
well as quality assurance for other endpoints utilized in clinical trials.
For more information on these services, please Contact Us or call 303.860.9900. |
