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Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT03161327
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Keith Pereira, MD:, St. Louis University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Peripheral Artery Disease
Amputation
Smoking
Diabetes
Hypercholesterolemia
Hypertension
Intervention Device: ABI using QuantaFlo™
Enrollment 238
Recruitment Details 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.
Pre-assignment Details Of the 1791 patients who completed the survey, 238 enrolled in the study (gave consent and completed digital ABI screening).
Arm/Group Title Patients at Risk for PAD
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 238
Completed 238
Not Completed 0
Arm/Group Title Patients at Risk for PAD
Hide Arm/Group Description 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 Number of Baseline Participants 206
Hide Baseline Analysis Population Description
238-missing 32 data sheets = 206
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants
<=18 years
0
   0.0%
Between 18 and 65 years
125
  60.7%
>=65 years
81
  39.3%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
All patients at risk for PAD Number Analyzed 206 participants
59.9  (13.1)
ABI severe risk Number Analyzed 10 participants
68.2  (8.5)
ABI moderate risk Number Analyzed 15 participants
65.6  (9.2)
ABI mild risk Number Analyzed 19 participants
67.1  (15.5)
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
ABI severe risk Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
ABI moderate risk Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
ABI mild risk Number Analyzed 19 participants
Female
16
  84.2%
Male
3
  15.8%
All patients at risk for PAD Number Analyzed 206 participants
Female
128
  62.1%
Male
78
  37.9%
[1]
Measure Analysis Population Description: 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.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
diabetic  
Measure Type: Count of Participants
Unit of measure:  Participants
Pateients at risk for PAD Number Analyzed 206 participants
100
  48.5%
ABI severe risk Number Analyzed 206 participants
6
   2.9%
ABI moderate risk Number Analyzed 206 participants
11
   5.3%
ABI mild risk Number Analyzed 206 participants
11
   5.3%
1.Primary Outcome
Title Positive Predictive Value of Digital ABI in Diagnosing PAD
Hide Description To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and ‘gold standard’ angiography as reference.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Positive Predictive Value (PPV)
Arm/Group Title ABI Severe Risk ABI Moderate-mild Risk
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 10 34
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
2
   5.9%
Time Frame Data was collected over the time of performing the non invasive ABI test. This was for 2 months
Adverse Event Reporting Description

Adverse Even (AE) any adverse event occurring at the time of or following time of procedure/ embolization through the remainder of study.

Serious Adverse Event (SAE):

  • death during the period of protocol defined surveillance
  • persistent or significant disability/incapacity.

Unanticipated Adverse Event (UAE): any event that could not be reasonably foreseen or had not been previously reported in the product package insert as a potential adverse event related to use of this device

 
Arm/Group Title ABIABI Using QuantaFlo™
Hide Arm/Group Description

ABI will be performed in patient

ABI using QuantaFlo™: Perform Digital ABI:

  • Will be performed by the nurse/medical assistant with training to perform this test
  • The patient will be placed in the supine position, with the arms and legs at the same level as the heart, for a minimum of 5 minutes before measurement.
  • The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the hands and feet: Right and left hand fingers and then right and left feet toes.
  • Usually each digit takes about 15 seconds to obtain a waveform
  • At the end of 60 seconds, an automated digital ABI will be generated.

Clinical course: If based on Screening questionnaire and digital ABI, I. Patient is diagnosed 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.

II. There is no evidence of PAD- no further action will be taken. The patient will be informed

All-Cause Mortality
ABIABI Using QuantaFlo™
Affected / at Risk (%)
Total   0/238 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ABIABI Using QuantaFlo™
Affected / at Risk (%)
Total   0/238 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABIABI Using QuantaFlo™
Affected / at Risk (%)
Total   0/238 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Keith Pereira
Organization: Saint Louis University
Phone: 314-268-5782
Responsible Party: Keith Pereira, MD:, St. Louis University
ClinicalTrials.gov Identifier: NCT03161327     History of Changes
Other Study ID Numbers: 28225
First Submitted: May 18, 2017
First Posted: May 19, 2017
Results First Submitted: August 16, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018