ID

31476

Description

Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00781950

Link

https://clinicaltrials.gov/show/NCT00781950

Keywords

Versions (1)
  1. 8/27/18 8/27/18 -
Copyright Holder

See clinicaltrials.gov

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August 27, 2018

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License

Creative Commons BY 4.0
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Eligibility Peripheral Arterial Disease NCT00781950

English

Eligibility Peripheral Arterial Disease NCT00781950

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with peripheral arterial disease for more than 6 months.
Description

Peripheral Arterial Disease Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C1704436
UMLS CUI [1,2]
C0872146
male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited ic but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
Description

Claudication Secondary to ARTERIOSCLEROSIS OF LOWER EXTREMITY | Ankle brachial pressure index Leg | Ankle brachial pressure index Both legs | Intervention Previous Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1456822
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0518957
UMLS CUI [2,1]
C1276055
UMLS CUI [2,2]
C1140621
UMLS CUI [3,1]
C1276055
UMLS CUI [3,2]
C0230446
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C1704436
over 40 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
able to comply with protocol requirements
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
Description

Antiplatelet Agents Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.
Description

Hypolipidemic Agents Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with ischemic rest pain in limbs, ulceration, or gangrene.
Description

Rest pain Ischemic Limbs | Ulceration | Gangrene

Data type

boolean

Alias
UMLS CUI [1,1]
C0234253
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C0015385
UMLS CUI [2]
C3887532
UMLS CUI [3]
C0017086
at baseline, any condition that prevents walking on a treadmill.
Description

Condition Preventing Walking Treadmill

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0080331
UMLS CUI [1,4]
C0184069
history of major bleeding.
Description

Hemorrhage Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
patients with bowel disease (including crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
Description

Intestinal Disease | Crohn Disease | Celiac Disease | Peptic Ulcer | Irritable Bowel Syndrome | Diverticulosis

Data type

boolean

Alias
UMLS CUI [1]
C0021831
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0007570
UMLS CUI [4]
C0030920
UMLS CUI [5]
C0022104
UMLS CUI [6]
C1510475
patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with ef<40%, canadian cardiovascular society class 3 or 4 angina or need for coronary revascularization procedures).
Description

Life Expectancy | Risk factors cardiac high | Status post Ischemic cardiomyopathy | Status post Diabetic Cardiomyopathy | Cardiac ejection fraction | Angina Pectoris CCS Grading Scale Class | Patient need for Coronary revascularisation

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C3693584
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0349782
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0853897
UMLS CUI [5]
C0232174
UMLS CUI [6,1]
C0002962
UMLS CUI [6,2]
C1879987
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C0877341
moderate to severe renal failure.
Description

RENAL FAILURE MODERATE | Kidney Failure Severe

Data type

boolean

Alias
UMLS CUI [1]
C0748307
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C0205082
subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
Description

Supplements | Exception Prescription Supplements

Data type

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0033080
UMLS CUI [2,3]
C0242295
fish limitations (no more than 2 fish meals per week)
Description

Fish Limitation | Fish Meal Quantity per week

Data type

boolean

Alias
UMLS CUI [1,1]
C4521129
UMLS CUI [1,2]
C0449295
UMLS CUI [2,1]
C4521129
UMLS CUI [2,2]
C1998602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0332174
gluten allergy
Description

Hypersensitivity Gluten

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2362561
subjects with allergies to any ingredient in the study product or placebo.
Description

Hypersensitivity Investigational New Drugs Ingredient | Hypersensitivity Placebo Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1696465
UMLS CUI [2,3]
C1550600
patients who plan to undergo surgery during the course of the trial.
Description

Operative Surgical Procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
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Similar models

Eligibility Peripheral Arterial Disease NCT00781950

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Peripheral Arterial Disease Disease length
Item
subjects with peripheral arterial disease for more than 6 months.
boolean
C1704436 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Claudication Secondary to ARTERIOSCLEROSIS OF LOWER EXTREMITY | Ankle brachial pressure index Leg | Ankle brachial pressure index Both legs | Intervention Previous Peripheral Arterial Disease
Item
male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited ic but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
boolean
C1456822 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0518957 (UMLS CUI [1,3])
C1276055 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C1276055 (UMLS CUI [3,1])
C0230446 (UMLS CUI [3,2])
C0184661 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1704436 (UMLS CUI [4,3])
Age
Item
over 40 years old
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with protocol requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Antiplatelet Agents Dosage Stable
Item
subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
boolean
C0085826 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Hypolipidemic Agents Dosage Stable
Item
subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.
boolean
C0086440 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Rest pain Ischemic Limbs | Ulceration | Gangrene
Item
patients with ischemic rest pain in limbs, ulceration, or gangrene.
boolean
C0234253 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C3887532 (UMLS CUI [2])
C0017086 (UMLS CUI [3])
Condition Preventing Walking Treadmill
Item
at baseline, any condition that prevents walking on a treadmill.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0184069 (UMLS CUI [1,4])
Hemorrhage Major
Item
history of major bleeding.
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Intestinal Disease | Crohn Disease | Celiac Disease | Peptic Ulcer | Irritable Bowel Syndrome | Diverticulosis
Item
patients with bowel disease (including crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
boolean
C0021831 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0007570 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C0022104 (UMLS CUI [5])
C1510475 (UMLS CUI [6])
Life Expectancy | Risk factors cardiac high | Status post Ischemic cardiomyopathy | Status post Diabetic Cardiomyopathy | Cardiac ejection fraction | Angina Pectoris CCS Grading Scale Class | Patient need for Coronary revascularisation
Item
patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with ef<40%, canadian cardiovascular society class 3 or 4 angina or need for coronary revascularization procedures).
boolean
C0023671 (UMLS CUI [1])
C3693584 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0349782 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0853897 (UMLS CUI [4,2])
C0232174 (UMLS CUI [5])
C0002962 (UMLS CUI [6,1])
C1879987 (UMLS CUI [6,2])
C0686904 (UMLS CUI [7,1])
C0877341 (UMLS CUI [7,2])
RENAL FAILURE MODERATE | Kidney Failure Severe
Item
moderate to severe renal failure.
boolean
C0748307 (UMLS CUI [1])
C0035078 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Supplements | Exception Prescription Supplements
Item
subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
boolean
C0242295 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0033080 (UMLS CUI [2,2])
C0242295 (UMLS CUI [2,3])
Fish Limitation | Fish Meal Quantity per week
Item
fish limitations (no more than 2 fish meals per week)
boolean
C4521129 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C4521129 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332174 (UMLS CUI [2,4])
Hypersensitivity Gluten
Item
gluten allergy
boolean
C0020517 (UMLS CUI [1,1])
C2362561 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs Ingredient | Hypersensitivity Placebo Ingredient
Item
subjects with allergies to any ingredient in the study product or placebo.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Operative Surgical Procedures Planned
Item
patients who plan to undergo surgery during the course of the trial.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
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