ID

16652

Beschrijving

Heredity and Phenotype Intervention (HAPI) Heart Study; ODM derived from: https://clinicaltrials.gov/show/NCT00664040

Link

https://clinicaltrials.gov/show/NCT00664040

Trefwoorden

Versies (3)
  1. 29-07-16 29-07-16 -
  2. 31-07-16 31-07-16 -
  3. 17-09-21 17-09-21 -
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29 juli 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Cardiovascular Diseases NCT00664040

Engels

Eligibility Cardiovascular Diseases NCT00664040

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant of amish family calcification study or related to a afcs participant and at least 20 years old.
Beschrijving

Study Subject Participation Status | Calcification Study Amish | Study Subject Participation Status Relative | Age

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1533591
UMLS CUI [2,2]
C0008972
UMLS CUI [2,3]
C0238622
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0080103
UMLS CUI [4]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
excluded for the entire study if the subject-
Beschrijving

ID.2

Datatype

boolean

1. is currently pregnant; however they will become eligible six months after delivery.
Beschrijving

Pregnancy | Delivery

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0011209
2. has severe hypertension (bp > 180/105), making it unethical not to recommend prompt treatment.
Beschrijving

Severe Hypertension Requirement Therapeutic procedure | Blood Pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0005823
3. takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation. these medications include anti-hypertensive agents (e.g., beta-blockers, calcium channel antagonists, ace inhibitors, and diuretics), lipid lowering agents, nitrates, systemic glucocorticoids, adrenergic or cholinergic-acting agents including cold formulas and antidepressants, and diet/weight loss agents.
Beschrijving

Pharmaceutical Preparations Affecting research results | Pharmaceutical Preparations Discontinuation Unable | Antihypertensive Agents | Adrenergic beta-Antagonists | Calcium Channel Blockers | Angiotensin-Converting Enzyme Inhibitors | Diuretics | Antilipemic agent | Nitrates | Glucocorticoids, Systemic | Adrenergic Agents | Cholinergic Agents | Common Cold Prescription | Antidepressive Agents | Diet Pharmaceutical Preparations | Weight-Loss Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0457454
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0003364
UMLS CUI [4]
C0001645
UMLS CUI [5]
C0006684
UMLS CUI [6]
C0003015
UMLS CUI [7]
C0012798
UMLS CUI [8]
C0003367
UMLS CUI [9]
C0028125
UMLS CUI [10]
C3540777
UMLS CUI [11]
C0001637
UMLS CUI [12]
C0242893
UMLS CUI [13,1]
C0009443
UMLS CUI [13,2]
C0033080
UMLS CUI [14]
C0003289
UMLS CUI [15,1]
C0012155
UMLS CUI [15,2]
C0013227
UMLS CUI [16]
C0376606
4. is taking vitamins and are unwilling to discontinue their use for at least 1 week prior to study.
Beschrijving

Vitamins | Vitamins Discontinuation Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0042890
UMLS CUI [2,1]
C0042890
UMLS CUI [2,2]
C0457454
UMLS CUI [2,3]
C0558080
5. has a coexisting malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
6. has a creatinine greater than 2.0, ast or alt greater than 2 times the upper limit of normal, hct less than 32, or a tsh less than 0.4 or greater than 5.5.
Beschrijving

Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Hematocrit level | Thyroid stimulating hormone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0518014
UMLS CUI [5]
C0202230
excluded from the cold pressor test if the subject-
Beschrijving

Cold pressor test

Datatype

boolean

Alias
UMLS CUI [1]
C0444689
1. has raynaud's disease or symptoms
Beschrijving

Raynaud Disease | Symptoms Raynaud Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0034734
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0034734
excluded from the high fat challenge if the subject-
Beschrijving

High fat Challenge

Datatype

boolean

Alias
UMLS CUI [1,1]
C0453819
UMLS CUI [1,2]
C0805586
1. has a malabsorption disorder or lactose intolerance
Beschrijving

Malabsorption Syndrome | Lactose Intolerance

Datatype

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0022951
2. has symptoms of gall bladder disease or history of pancreatitis
Beschrijving

Gall Bladder Diseases Symptoms | Pancreatitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0030305
excluded from the dietary salt intervention if the subject-
Beschrijving

Dietary salt intake

Datatype

boolean

Alias
UMLS CUI [1]
C0425431
1. has stage iii or greater congestive heart failure
Beschrijving

Congestive heart failure | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C1275491
2. has food allergies to foods included in the diet
Beschrijving

Food Allergy Diet Food

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016470
UMLS CUI [1,2]
C0012155
UMLS CUI [1,3]
C0016452
excluded from the aspirin intervention if the subject-
Beschrijving

Aspirin Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0087111
1. has a bleeding disorder or history of gastrointestinal bleeding
Beschrijving

Blood Coagulation Disorder | Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0017181
2. has a blood pressure greater than 160/95
Beschrijving

Blood Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
3. is currently taking aspirin and have conditions that might place them at increased risk from aspirin withdrawal 14 days prior to protocol initiation, including history of unstable angina, mi, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, type 2 diabetes, or deep vein thrombosis or other thrombosis
Beschrijving

Aspirin | Condition Aspirin Withdrawal Risk Increased | Angina, Unstable | Myocardial Infarction | Angioplasty | Placement of stent | Coronary Artery Bypass Surgery | Atrial Fibrillation | Cerebrovascular accident | Transient Ischemic Attack | Diabetes Mellitus, Non-Insulin-Dependent | Deep Vein Thrombosis | Thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0004057
UMLS CUI [2,3]
C2349954
UMLS CUI [2,4]
C0035647
UMLS CUI [2,5]
C0205217
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0162577
UMLS CUI [6]
C0522776
UMLS CUI [7]
C0010055
UMLS CUI [8]
C0004238
UMLS CUI [9]
C0038454
UMLS CUI [10]
C0007787
UMLS CUI [11]
C0011860
UMLS CUI [12]
C0149871
UMLS CUI [13]
C0040053
4. has polycythemia, or thrombocytosis (platelet count greater than 500,000)
Beschrijving

Polycythemia | Thrombocytosis | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032461
UMLS CUI [2]
C0836924
UMLS CUI [3]
C0032181
5. has thrombocytopenia (platelet count less than 75,000)
Beschrijving

Thrombocytopenia | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
6. has had surgery within the last 6 months
Beschrijving

Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
7. has an aspirin allergy
Beschrijving

Aspirin allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0004058
8. is currently breast feeding
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
9. aggregation with collagen 5 micrograms/ml is less than 7 ohms or greater than 31 ohms, or no aggregation at baseline with arachadonic acid
Beschrijving

Collagen induced platelet aggregation | Aggregation | Arachidonic Acid

Datatype

boolean

Alias
UMLS CUI [1]
C0369863
UMLS CUI [2]
C0332621
UMLS CUI [3]
C0003695
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Similar models

Eligibility Cardiovascular Diseases NCT00664040

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Calcification Study Amish | Study Subject Participation Status Relative | Age
Item
participant of amish family calcification study or related to a afcs participant and at least 20 years old.
boolean
C2348568 (UMLS CUI [1])
C1533591 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0238622 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3,1])
C0080103 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
ID.2
Item
excluded for the entire study if the subject-
boolean
Pregnancy | Delivery
Item
1. is currently pregnant; however they will become eligible six months after delivery.
boolean
C0032961 (UMLS CUI [1])
C0011209 (UMLS CUI [2])
Severe Hypertension Requirement Therapeutic procedure | Blood Pressure
Item
2. has severe hypertension (bp > 180/105), making it unethical not to recommend prompt treatment.
boolean
C4013784 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2])
Pharmaceutical Preparations Affecting research results | Pharmaceutical Preparations Discontinuation Unable | Antihypertensive Agents | Adrenergic beta-Antagonists | Calcium Channel Blockers | Angiotensin-Converting Enzyme Inhibitors | Diuretics | Antilipemic agent | Nitrates | Glucocorticoids, Systemic | Adrenergic Agents | Cholinergic Agents | Common Cold Prescription | Antidepressive Agents | Diet Pharmaceutical Preparations | Weight-Loss Agents
Item
3. takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation. these medications include anti-hypertensive agents (e.g., beta-blockers, calcium channel antagonists, ace inhibitors, and diuretics), lipid lowering agents, nitrates, systemic glucocorticoids, adrenergic or cholinergic-acting agents including cold formulas and antidepressants, and diet/weight loss agents.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C0006684 (UMLS CUI [5])
C0003015 (UMLS CUI [6])
C0012798 (UMLS CUI [7])
C0003367 (UMLS CUI [8])
C0028125 (UMLS CUI [9])
C3540777 (UMLS CUI [10])
C0001637 (UMLS CUI [11])
C0242893 (UMLS CUI [12])
C0009443 (UMLS CUI [13,1])
C0033080 (UMLS CUI [13,2])
C0003289 (UMLS CUI [14])
C0012155 (UMLS CUI [15,1])
C0013227 (UMLS CUI [15,2])
C0376606 (UMLS CUI [16])
Vitamins | Vitamins Discontinuation Unwilling
Item
4. is taking vitamins and are unwilling to discontinue their use for at least 1 week prior to study.
boolean
C0042890 (UMLS CUI [1])
C0042890 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Malignant Neoplasms
Item
5. has a coexisting malignancy
boolean
C0006826 (UMLS CUI [1])
Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Hematocrit level | Thyroid stimulating hormone measurement
Item
6. has a creatinine greater than 2.0, ast or alt greater than 2 times the upper limit of normal, hct less than 32, or a tsh less than 0.4 or greater than 5.5.
boolean
C0201976 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0518014 (UMLS CUI [4])
C0202230 (UMLS CUI [5])
Cold pressor test
Item
excluded from the cold pressor test if the subject-
boolean
C0444689 (UMLS CUI [1])
Raynaud Disease | Symptoms Raynaud Disease
Item
1. has raynaud's disease or symptoms
boolean
C0034734 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0034734 (UMLS CUI [2,2])
High fat Challenge
Item
excluded from the high fat challenge if the subject-
boolean
C0453819 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
Malabsorption Syndrome | Lactose Intolerance
Item
1. has a malabsorption disorder or lactose intolerance
boolean
C0024523 (UMLS CUI [1])
C0022951 (UMLS CUI [2])
Gall Bladder Diseases Symptoms | Pancreatitis
Item
2. has symptoms of gall bladder disease or history of pancreatitis
boolean
C0016977 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
Dietary salt intake
Item
excluded from the dietary salt intervention if the subject-
boolean
C0425431 (UMLS CUI [1])
Congestive heart failure | New York Heart Association Classification
Item
1. has stage iii or greater congestive heart failure
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Food Allergy Diet Food
Item
2. has food allergies to foods included in the diet
boolean
C0016470 (UMLS CUI [1,1])
C0012155 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
Aspirin Therapeutic procedure
Item
excluded from the aspirin intervention if the subject-
boolean
C0004057 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Blood Coagulation Disorder | Gastrointestinal Hemorrhage
Item
1. has a bleeding disorder or history of gastrointestinal bleeding
boolean
C0005779 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Blood Pressure
Item
2. has a blood pressure greater than 160/95
boolean
C0005823 (UMLS CUI [1])
Aspirin | Condition Aspirin Withdrawal Risk Increased | Angina, Unstable | Myocardial Infarction | Angioplasty | Placement of stent | Coronary Artery Bypass Surgery | Atrial Fibrillation | Cerebrovascular accident | Transient Ischemic Attack | Diabetes Mellitus, Non-Insulin-Dependent | Deep Vein Thrombosis | Thrombosis
Item
3. is currently taking aspirin and have conditions that might place them at increased risk from aspirin withdrawal 14 days prior to protocol initiation, including history of unstable angina, mi, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, type 2 diabetes, or deep vein thrombosis or other thrombosis
boolean
C0004057 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
C0205217 (UMLS CUI [2,5])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0162577 (UMLS CUI [5])
C0522776 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
C0004238 (UMLS CUI [8])
C0038454 (UMLS CUI [9])
C0007787 (UMLS CUI [10])
C0011860 (UMLS CUI [11])
C0149871 (UMLS CUI [12])
C0040053 (UMLS CUI [13])
Polycythemia | Thrombocytosis | Platelet Count measurement
Item
4. has polycythemia, or thrombocytosis (platelet count greater than 500,000)
boolean
C0032461 (UMLS CUI [1])
C0836924 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Thrombocytopenia | Platelet Count measurement
Item
5. has thrombocytopenia (platelet count less than 75,000)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Operative Surgical Procedures
Item
6. has had surgery within the last 6 months
boolean
C0543467 (UMLS CUI [1])
Aspirin allergy
Item
7. has an aspirin allergy
boolean
C0004058 (UMLS CUI [1])
Breast Feeding
Item
8. is currently breast feeding
boolean
C0006147 (UMLS CUI [1])
Collagen induced platelet aggregation | Aggregation | Arachidonic Acid
Item
9. aggregation with collagen 5 micrograms/ml is less than 7 ohms or greater than 31 ohms, or no aggregation at baseline with arachadonic acid
boolean
C0369863 (UMLS CUI [1])
C0332621 (UMLS CUI [2])
C0003695 (UMLS CUI [3])
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