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Sponsor decision to terminate study prior to reaching full sample size.
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
Patients scheduled for peripheral vascular examination and healthy controls will be measured with the FlowMet-R, a noninvasive blood flow monitor, and compared to gold standard diagnostics - ABI, TBI, and Doppler Ultrasound. Sensitivity and specificity of the FlowMet-R device output in diagnosing PAD and CLI will be assessed on initial visit, 3-month followup, and 6-month followup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Healthy cohort is an age-matched population (over 40 years old) without history of PAD or suspected PAD. Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements. |
| |
| Peripheral Artery Disease | PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD and will receive FlowMet-R measurement in addition to their routine standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlowMet-R | Diagnostic Test | FlowMet-R is a noninvasive blood flow measurement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI | Primary objective is to determine the efficacy of FlowMet-R measurements in diagnosing PAD & CLI. All patients were combined from healthy & PAD groups to form one cohort, ABI and TBI were then used to assign patients in PAD (1), PAD (2) & CLI. FlowMet-R data (comprised of blood flow measurements and/or feature analysis of the blood flow waveform) were used to create a predictive model of PAD severity. This model was used to generate diagnostic receiver operating characteristic (ROC) curves for PAD and, independently, CLI, at three time points. ROC curves were used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) at the initial, 3-month and 6-month time points. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). | Initial, three month, and six month time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of FlowMet-R for Prognosis of Requiring a Peripheral Vascular Intervention | ROC curves for predicting if a patient will undergo intervention following their initial visit were generated using FlowMet-R measurement data. ROC curves were used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) within the 3-month and 6-month time points, separately. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). |
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Inclusion Criteria:
PAD Positive Cohort
Healthy Cohort
Exclusion Criteria:
PAD Positive Cohort
Healthy Cohort
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The PAD cohort population is persons who have known or suspected peripheral artery disease, and are being seen at a vascular clinic for evaluation.
The Healthy cohort population is adult persons over 40 without history of PAD and who are not currently suspected of suffering from PAD.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Iowa Clinic | Des Moines | Iowa | 50266 | United States | ||
| Mercy Research |
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205 subjects were consented in the study. Of the 205 subjects, 10 subjects were screen fails due to I/E criteria, resulting in 195 total subjects enrolled.
There were limitations discovered in the study design during enrollment due to classification of PAD and CLI from respective sites. Patients were categorized based on observed ABI, TBI and Rutherford Classification regardless of enrollment cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Healthy cohort includes patients over 40 years old without history of PAD or suspected PAD, where the ABI>0.9 and ABI≤1.4 or TBI>0.7. Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
| FG001 | Peripheral Artery Disease | PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD. PAD cohort patients will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Site-reported demographic and medical history data are presented based on the assigned cohort using the definitions for Healthy and PAD (2) in the Groups and Interventions Section. Baseline information was not collected for one participant; therefore, a total of 194 participants were included in baseline analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Healthy cohort includes patients over 40 years old without history of PAD or suspected PAD, where the ABI>0.9 and ABI≤1.4 or TBI>0.7. Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI | Primary objective is to determine the efficacy of FlowMet-R measurements in diagnosing PAD & CLI. All patients were combined from healthy & PAD groups to form one cohort, ABI and TBI were then used to assign patients in PAD (1), PAD (2) & CLI. FlowMet-R data (comprised of blood flow measurements and/or feature analysis of the blood flow waveform) were used to create a predictive model of PAD severity. This model was used to generate diagnostic receiver operating characteristic (ROC) curves for PAD and, independently, CLI, at three time points. ROC curves were used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) at the initial, 3-month and 6-month time points. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). | Sensitivity, specificity and area under the curve (AUC) were calculated for PAD (1) vs. not PAD (1), PAD (2) vs not PAD (2), and CLI vs. not CLI at initial, three-month and six-month timepoints. | Posted | Number | 95% Confidence Interval | probability | Initial, three month, and six month time points. | limbs | limbs |
Adverse events were collected from the baseline assessment visit throughout 6-month follow-up.
Investigators submitted device-related or suspected device-related AE or SAE to the sponsor and IRB within 5 business days after awareness. Sites were required to only include AEs that were reasonably associated with use of the FlowMet-R device. Investigators classified whether an AE was considered serious, non-serious and device related. All SAEs and AEs collected as part of the study are reported, including device- & non-device related events. All deaths reported on the Exit form are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy | Healthy cohort is an age-matched population (over 40 years old) without history of PAD or suspected PAD. Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amputation | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain during FlowMet-R Assessment | Injury, poisoning and procedural complications | Non-systematic Assessment | Pain on first Digit due to device, temporarily removed device during procedure |
The study was terminated by Medtronic prior to completing enrollment. Difficulties with enrollment and limited compliance partially related to the COVID-19 pandemic limited the conclusions. Analyses described in the protocol were computed, but no hypothesis tests were completed. The AUC and its 95% CI are provided to assess the potential for the FlowMet device to classify CLI, PAD (1), PAD (2) at 0-, 3-, and 6-months, reintervention within 3- and 6-months, and significant stenosis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janki Shah | Medtronic | 732-266-2503 | janki.shah@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2020 | Apr 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2023 | Apr 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Not provided
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| ABI | Diagnostic Test | Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. |
|
| TBI | Diagnostic Test | Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
|
| Within three and six months following initial visit |
| Sensitivity, Specificity and Area Under the Curve (AUC) of FlowMet-R in Diagnosing Significant Stenosis | ROC curves for predicting a patient has significant stenosis, defined by greater than 50%, in at least one peripheral artery will be generated using FlowMet-R measurement data. ROC curves will be used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) at the initial visit. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). | Initial visit |
| Stenosis Percentage | A correlation test will be performed between FlowMet-R and stenosis percentage. The correlations between the acceleration time from the FlowMet-R device and peripheral artery stenosis will be computed using a Pearson correlation. Correlation will be computed using available FlowMet-R data from PAD participants with significant stenosis, defined by greater than 50%, in at least one peripheral artery at the initial visit. | Initial visit |
| Changes in Ankle Brachial Index (ABI) | The outcome ABI is a ratio of blood pressures in the arm and ankle. Values less than 1 generally indicate narrower arteries. The outcome used the change in ABI for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Within three and six months following initial visit. |
| Changes in Toe Brachial Index (TBI) | The outcome TBI is a ratio of blood pressures in the arm and toe. Values less than 1 generally indicate narrower arteries. The outcome used the change in TBI for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Within three and six months following initial visit. |
| Changes in Rutherford Classification | Rutherford Classification is an ordinal scale that ranges from 0 to 6 and is used to measure peripheral arterial disease severity and chronic limb threatening ischemia. Higher values indicate more severe disease. The changes for Rutherford Classification were computed for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Within three and six months following initial visit. |
| Chesterfield |
| Missouri |
| 63017 |
| United States |
| The Mt. Sinai Hospital | New York | New York | 10029 | United States |
| Ohio Health | Columbus | Ohio | 43214 | United States |
| Ascension Seton | Austin | Texas | 78705 | United States |
| BG001 | Peripheral Artery Disease (Including Critical Limb Ischemia) | PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD. PAD (2) cohort patients are defined by ABI≤0.9 or ABI>1.4 and secondary verification of TBI≤0.7 without exhibition of symptoms and regardless of Rutherford Category. CLI cohort patients are defined by an exhibition of chronic rest pain and active wounds, verified by TBI<0.3. PAD (2) and CLI patients will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. |
| BG002 | Total | Total of all reporting groups |
| limbs |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Weight | Data not collected for 4 healthy participants | Mean | Standard Deviation | pounds | Participants |
|
|
| Height | Data not collected for 4 healthy participants | Mean | Standard Deviation | inches | Participants |
|
|
| Body Mass Index | Data not collected for 4 healthy participants | Mean | Standard Deviation | lbs/(in^2)*703 | Participants |
|
|
| Medical History | Number | participants | Participants |
|
|
| Wound History | Count of Participants | Participants | Participants |
|
|
| Smoking Status | Count of Participants | Participants | Participants |
|
|
| ID | Title | Description |
|---|---|---|
| OG000 | Peripheral Artery Disease (1) vs Not PAD | All patients were assigned PAD (1) by the following criteria: ABI≤0.9 or ABI>1.4 and secondary verification of TBI≤0.7 with exhibition of at least mild claudication (Rutherford Category>0) and will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. Not PAD are patients that did not meet the definition above. |
| OG001 | Peripheral Artery Disease (2) vs Not PAD | All patients were assigned PAD (2) by the following criteria: ABI≤0.9 or ABI>1.4 and secondary verification of TBI≤0.7 without exhibition of symptoms and will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. Not PAD are patients that did not meet the definition above. |
| OG002 | Critical Limb Ischemia (CLI) vs Not CLI | All patients were assigned CLI based on exhibition of chronic rest pain and active wounds, verified by TBI<0.3. CLI cohort patients will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. Not CLI are patients that did not meet the definition above. |
|
|
| Secondary | Sensitivity and Specificity of FlowMet-R for Prognosis of Requiring a Peripheral Vascular Intervention | ROC curves for predicting if a patient will undergo intervention following their initial visit were generated using FlowMet-R measurement data. ROC curves were used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) within the 3-month and 6-month time points, separately. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). | PAD (1), PAD (2) and CLI participants who underwent vascular intervention following their initial visit. | Posted | Number | 95% Confidence Interval | probability | Within three and six months following initial visit | limbs | limbs |
|
|
|
| Secondary | Sensitivity, Specificity and Area Under the Curve (AUC) of FlowMet-R in Diagnosing Significant Stenosis | ROC curves for predicting a patient has significant stenosis, defined by greater than 50%, in at least one peripheral artery will be generated using FlowMet-R measurement data. ROC curves will be used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) at the initial visit. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives & specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak). | All PAD participants with significant stenosis, defined by greater than 50%, in at least one peripheral artery and generated using FlowMet-R measurement data. | Posted | Number | 95% Confidence Interval | probability | Initial visit | limbs | limbs |
|
|
|
| Secondary | Stenosis Percentage | A correlation test will be performed between FlowMet-R and stenosis percentage. The correlations between the acceleration time from the FlowMet-R device and peripheral artery stenosis will be computed using a Pearson correlation. Correlation will be computed using available FlowMet-R data from PAD participants with significant stenosis, defined by greater than 50%, in at least one peripheral artery at the initial visit. | All limbs of PAD participants with significant stenosis, defined by greater than 50%, in at least one peripheral artery and generated using FlowMet-R measurement data. | Posted | Mean | Standard Deviation | percentage of stenosis | Initial visit | limbs | limbs |
|
|
|
|
| Secondary | Changes in Ankle Brachial Index (ABI) | The outcome ABI is a ratio of blood pressures in the arm and ankle. Values less than 1 generally indicate narrower arteries. The outcome used the change in ABI for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Limbs of participants with ABI measured at 0, 3, and 6 months. ABI was not collected in at least 2 of the 86 limbs included in the overall analysis. | Posted | Mean | Standard Deviation | mmHg / mmHg | Within three and six months following initial visit. | limbs | limbs |
|
|
|
|
| Secondary | Changes in Toe Brachial Index (TBI) | The outcome TBI is a ratio of blood pressures in the arm and toe. Values less than 1 generally indicate narrower arteries. The outcome used the change in TBI for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Limbs of participants with TBI measured at 0, 3, and 6 months. | Posted | Mean | Standard Deviation | mmHg / mmHg | Within three and six months following initial visit. | limbs | limbs |
|
|
|
|
| Secondary | Changes in Rutherford Classification | Rutherford Classification is an ordinal scale that ranges from 0 to 6 and is used to measure peripheral arterial disease severity and chronic limb threatening ischemia. Higher values indicate more severe disease. The changes for Rutherford Classification were computed for: 0 to 3 months, 0 to 6 months, and 3 to 6 months. The correlation with this outcome was estimated using the corresponding change in acceleration time from the FlowMet-R device. | Limbs of participants with Rutherford Class measured at 0, 3, and 6 months. Rutherford Class was not collected in at least 2 of the 86 limbs included in the overall analysis. | Posted | Mean | Standard Deviation | units on a scale | Within three and six months following initial visit. | limbs | limbs |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Peripheral Artery Disease | PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD. PAD cohort patients will receive FlowMet-R measurement in addition to their routine standard of care. FlowMet-R: FlowMet-R is a noninvasive blood flow measurement. ABI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm. TBI: Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm. | 4 | 143 | 6 | 143 | 2 | 143 |
| Femoral Artery Bypass | Surgical and medical procedures | Non-systematic Assessment |
|
| Femorofemoral Bypass | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-Healing Left Leg Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
|
|
| Hematoma | Vascular disorders | Non-systematic Assessment | Hematoma in Left Groin |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007511 | Ischemia |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Type 2 diabetes |
|
| Clots or deep vein thrombosis (DVT) |
|
| Venous Disease |
|
| Never |
|
|
|
|
|
|
|
|
|
| Area Under the Curve (AUC) |
|
| Title | Measurements |
|---|---|
|
| Correlation |
| -0.33 |
| 2-Sided |
| 95 |
| -0.51 |
| -0.12 |
| Other |
| Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis. | Correlation | -0.13 | 2-Sided | 95 | -0.38 | 0.14 | Other |
| Correlation |
| -0.35 |
| 2-Sided |
| 95 |
| -0.52 |
| -0.15 |
| Other |
| Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis. | Correlation | -0.24 | 2-Sided | 95 | -0.47 | 0.02 | Other |
| Correlation |
| 0.19 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.39 |
| Other |
| Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis. | Correlation | 0.24 | 2-Sided | 95 | -0.02 | 0.47 | Other |