Trial Outcomes & Findings for Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease (NCT NCT03161327)
NCT ID: NCT03161327
Last Updated: 2018-12-11
Results Overview
To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and 'gold standard' angiography as reference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
3 months
Results posted on
2018-12-11
Participant Flow
This study recruited patients from various clinics presenting for appointments not necessarily related to PAD. Patients were asked to complete a screening questionnaire. 1791 patients completed the questionnaire. Patients giving any yes responses were asked if they wanted to participate in the study.
Of the 1791 patients who completed the survey, 238 enrolled in the study (gave consent and completed digital ABI screening).
Participant milestones
| Measure |
Patients at Risk for PAD
For those who screened positive by the questionnaire, and signed consent, a digital ABI was performed using QuantaFlo™. For subjects with PAD the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. For subjects with no evidence of PAD, subject will be informed of results, and no further action taken.
|
|---|---|
|
Overall Study
STARTED
|
238
|
|
Overall Study
COMPLETED
|
238
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
Baseline characteristics by cohort
| Measure |
Patients at Risk for PAD
n=206 Participants
For those who screened positive by the questionnaire, and signed consent, a digital ABI was performed using QuantaFlo™. For subjects with PAD the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. For subjects with no evidence of PAD, subject will be informed of results, and no further action taken.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
81 Participants
n=206 Participants
|
|
Age, Continuous
All patients at risk for PAD
|
59.9 years
STANDARD_DEVIATION 13.1 • n=206 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Age, Continuous
ABI severe risk
|
68.2 years
STANDARD_DEVIATION 8.5 • n=10 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Age, Continuous
ABI moderate risk
|
65.6 years
STANDARD_DEVIATION 9.2 • n=15 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Age, Continuous
ABI mild risk
|
67.1 years
STANDARD_DEVIATION 15.5 • n=19 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI severe risk · Female
|
6 Participants
n=10 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI severe risk · Male
|
4 Participants
n=10 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI moderate risk · Female
|
9 Participants
n=15 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI moderate risk · Male
|
6 Participants
n=15 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI mild risk · Female
|
16 Participants
n=19 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
ABI mild risk · Male
|
3 Participants
n=19 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
All patients at risk for PAD · Female
|
128 Participants
n=206 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
Sex: Female, Male
All patients at risk for PAD · Male
|
78 Participants
n=206 Participants • ABI severe, mod and mild risk categories are made up of subjects within the overall at risk for PAD population. These categories are based on ABI results of that population.
|
|
diabetic
Pateients at risk for PAD
|
100 Participants
n=206 Participants
|
|
diabetic
ABI severe risk
|
6 Participants
n=206 Participants
|
|
diabetic
ABI moderate risk
|
11 Participants
n=206 Participants
|
|
diabetic
ABI mild risk
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Positive Predictive Value (PPV)
To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and 'gold standard' angiography as reference.
Outcome measures
| Measure |
ABI Severe Risk
n=10 Participants
Those who screened at risk for PAD on questionnaire, had digital ABI performed, and if ABI \<0.4 , these were described as severe risk for PAD
|
ABI Moderate-mild Risk
n=34 Participants
Those who screened at risk for PAD on questionnaire, had digital ABI performed, and results were 0.4 to 0.9 , these were at moderate or mild risk for PAD
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|---|---|---|
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Positive Predictive Value of Digital ABI in Diagnosing PAD
|
8 Participants
|
2 Participants
|
Adverse Events
ABIABI Using QuantaFlo™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place