ID

45903

Description

Principal Investigator: Dan M. Roden, MD, Vanderbilt University, Nashville, TN, USA MeSH: Myocardial Revascularization,Myocardial Infarction https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000963 Coronary heart disease (CHD) is an important public health problem in developed countries. Statins are effective in the prevention and treatment of CHD; nevertheless, many patients receiving statins still suffer cardiovascular events (CV) such as heart attack. Identifying genetic variants responsible for differential clinical responses to statins will not only allow individual patients at high residual risk to be targeted for additional therapies, but also will define new biologic pathways contributing to statin response, and thus new targets for future therapies. Accordingly, the goal of this study is to identify genetic variants associated with clinical CV in patients receiving statins. Subjects identified for study are of European descent and include 1718 subjects with CV while on statins (cases) and 4172 subjects without CV while on statins (controls). Key research resources utilized in this effort include VanderbiltD's BioVU DNA databank and associated Synthetic Derivative database of clinical information, and software tools developed to identify drugs and clinical events using Electronic Health Record-derived structured and unstructured ("free text") data. Most cases and controls identified include three data types: ICD-9 codes, medication regimens, and medical test results. Genotyping, using IlluminaD's Infinium HumanOmniExpressExome BeadChip (OmniExpressExome), was performed by the RIKEN Integrative Medical Sciences Center (IMS) and supported by the Pharmacogenomics Research Network (PGRN)-RIKEN IMS Global Alliance.

Link

dbGaP study = phs000963

Keywords

Versions (1)
  1. 12/13/23 12/13/23 - Simon Heim
Copyright Holder

Dan M. Roden, MD, Vanderbilt University, Nashville, TN, USA

Uploaded on

December 13, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs000963 PGRN-RIKEN:Genetic Determinants of Cardiovascular Events while on Statins

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Case Inclusion:*
Description

*Case Inclusion:*

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
**AMI on statins: Case definition** (all three conditions required):
Description

**AMI on statins: Case definition** (all three conditions required):

Data type

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C4316157
At least two ICD9 code for AMI or other acute and subacute forms of ischemic heart disease within a five-day window
Description

At least two ICD9 code for AMI or other acute and subacute forms of ischemic heart disease within a five-day window

Data type

boolean

Alias
UMLS CUI [1,1]
C1550213
UMLS CUI [1,2]
C0155626
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0340283
UMLS CUI [1,5]
C0332168
Confirmed lab within the same time window
Description

Confirmed lab within the same time window

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0332168
Statin prescribed prior to the AMI event in medical records at least 180 days
Description

Statin prescribed prior to the AMI event in medical records at least 180 days

Data type

boolean

Alias
UMLS CUI [1,1]
C1314135
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0155626
UMLS CUI [1,4]
C0025102
UMLS CUI [1,5]
C0332168
**Revascularization while on statin: Case definition** (both conditions required):
Description

**Revascularization while on statin: Case definition** (both conditions required):

Data type

boolean

Alias
UMLS CUI [1,1]
C0027056
UMLS CUI [1,2]
C4316157
UMLS CUI [1,3]
C1706256
UMLS CUI [1,4]
C1704788
At least one revascularization CPT code
Description

At least one revascularization CPT code

Data type

boolean

Alias
UMLS CUI [1,1]
C0027056
UMLS CUI [1,2]
C1136322
Statin prescribed prior to the revascularization event in medical records at least 180 days
Description

Statin prescribed prior to the revascularization event in medical records at least 180 days

Data type

boolean

Alias
UMLS CUI [1,1]
C1314135
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0027056
UMLS CUI [1,4]
C0025102
UMLS CUI [1,5]
C0332168
*Case Exclusion:*
Description

*Case Exclusion:*

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
No diagnosis code for AMI, other acute and subacute forms of ischemic heart , or historical AMI assigned previously
Description

No diagnosis code for AMI, other acute and subacute forms of ischemic heart , or historical AMI assigned previously

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1550350
UMLS CUI [1,3]
C0155626
UMLS CUI [1,4]
C0340283
UMLS CUI [1,5]
C0262926
No revascularization CPT codes assigned previously
Description

No revascularization CPT codes assigned previously

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0027056
UMLS CUI [1,3]
C1136322
No MACE (Major Adverse Cardiovascular Events) found in previous problem list by NLP
Description

No MACE (Major Adverse Cardiovascular Events) found in previous problem list by NLP

Data type

boolean

Alias
UMLS CUI [1,1]
C5691385
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0552582
**Control definition**
Description

**Control definition**

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C1704788
Statin prescribed
Description

Statin prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C1314135
No diagnosis code for AMI, other acute and subacute forms of ischemic heart, or historical AMI assigned previously
Description

No diagnosis code for AMI, other acute and subacute forms of ischemic heart, or historical AMI assigned previously

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1550350
UMLS CUI [1,3]
C0155626
UMLS CUI [1,4]
C0340283
UMLS CUI [1,5]
C0262926
No revascularization CPT codes assigned previously
Description

No revascularization CPT codes assigned previously

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0027056
UMLS CUI [1,3]
C1136322
UMLS CUI [1,4]
C1516050
No MACE found in previous problem list by NLP
Description

No MACE found in previous problem list by NLP

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C5691385
UMLS CUI [1,3]
C0552582
Controls match cases by age, gender, statin type (e.g. simvastatin), and statin exposure.
Description

Controls match cases by age, gender, statin type (e.g. simvastatin), and statin exposure.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0150103
UMLS CUI [1,3]
C0079399
UMLS CUI [1,4]
C0001779
UMLS CUI [1,5]
C0075191
UMLS CUI [1,6]
C0332307
UMLS CUI [1,7]
C5826857
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Similar models

Eligibility Criteria

5 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
*Case Inclusion:*
Item
*Case Inclusion:*
boolean
C1512693 (UMLS CUI [1,1])
**AMI on statins: Case definition** (all three conditions required):
Item
**AMI on statins: Case definition** (all three conditions required):
boolean
C0155626 (UMLS CUI [1,1])
C4316157 (UMLS CUI [1,2])
At least two ICD9 code for AMI or other acute and subacute forms of ischemic heart disease within a five-day window
Item
At least two ICD9 code for AMI or other acute and subacute forms of ischemic heart disease within a five-day window
boolean
C1550213 (UMLS CUI [1,1])
C0155626 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0340283 (UMLS CUI [1,4])
C0332168 (UMLS CUI [1,5])
Confirmed lab within the same time window
Item
Confirmed lab within the same time window
boolean
C0022877 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0332168 (UMLS CUI [1,3])
Statin prescribed prior to the AMI event in medical records at least 180 days
Item
Statin prescribed prior to the AMI event in medical records at least 180 days
boolean
C1314135 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0155626 (UMLS CUI [1,3])
C0025102 (UMLS CUI [1,4])
C0332168 (UMLS CUI [1,5])
**Revascularization while on statin: Case definition** (both conditions required):
Item
**Revascularization while on statin: Case definition** (both conditions required):
boolean
C0027056 (UMLS CUI [1,1])
C4316157 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C1704788 (UMLS CUI [1,4])
At least one revascularization CPT code
Item
At least one revascularization CPT code
boolean
C0027056 (UMLS CUI [1,1])
C1136322 (UMLS CUI [1,2])
Statin prescribed prior to the revascularization event in medical records at least 180 days
Item
Statin prescribed prior to the revascularization event in medical records at least 180 days
boolean
C1314135 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0027056 (UMLS CUI [1,3])
C0025102 (UMLS CUI [1,4])
C0332168 (UMLS CUI [1,5])
*Case Exclusion:*
Item
*Case Exclusion:*
boolean
C0680251 (UMLS CUI [1,1])
No diagnosis code for AMI, other acute and subacute forms of ischemic heart , or historical AMI assigned previously
Item
No diagnosis code for AMI, other acute and subacute forms of ischemic heart , or historical AMI assigned previously
boolean
C1298908 (UMLS CUI [1,1])
C1550350 (UMLS CUI [1,2])
C0155626 (UMLS CUI [1,3])
C0340283 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
No revascularization CPT codes assigned previously
Item
No revascularization CPT codes assigned previously
boolean
C1298908 (UMLS CUI [1,1])
C0027056 (UMLS CUI [1,2])
C1136322 (UMLS CUI [1,3])
No MACE (Major Adverse Cardiovascular Events) found in previous problem list by NLP
Item
No MACE (Major Adverse Cardiovascular Events) found in previous problem list by NLP
boolean
C5691385 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0552582 (UMLS CUI [1,3])
**Control definition**
Item
**Control definition**
boolean
C0009932 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
Statin prescribed
Item
Statin prescribed
boolean
C1314135 (UMLS CUI [1,1])
No diagnosis code for AMI, other acute and subacute forms of ischemic heart, or historical AMI assigned previously
Item
No diagnosis code for AMI, other acute and subacute forms of ischemic heart, or historical AMI assigned previously
boolean
C1298908 (UMLS CUI [1,1])
C1550350 (UMLS CUI [1,2])
C0155626 (UMLS CUI [1,3])
C0340283 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
No revascularization CPT codes assigned previously
Item
No revascularization CPT codes assigned previously
boolean
C1298908 (UMLS CUI [1,1])
C0027056 (UMLS CUI [1,2])
C1136322 (UMLS CUI [1,3])
C1516050 (UMLS CUI [1,4])
No MACE found in previous problem list by NLP
Item
No MACE found in previous problem list by NLP
boolean
C1298908 (UMLS CUI [1,1])
C5691385 (UMLS CUI [1,2])
C0552582 (UMLS CUI [1,3])
Controls match cases by age, gender, statin type (e.g. simvastatin), and statin exposure.
Item
Controls match cases by age, gender, statin type (e.g. simvastatin), and statin exposure.
boolean
C0009932 (UMLS CUI [1,1])
C0150103 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
C0075191 (UMLS CUI [1,5])
C0332307 (UMLS CUI [1,6])
C5826857 (UMLS CUI [1,7])
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