ID

45694

Descrição

Principal Investigator: Sekar Kathiresan, MD, Broad Institute, Cambridge, MA, USA MeSH: Myocardial Infarction,Inferior Wall Myocardial Infarction,Anterior Wall Myocardial Infarction https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001259 The VIRGO study is a four year research project funded by the NHLBI to study young women and men with heart attacks. A total of 2,000 women who are 18 - 55 years of age and a smaller comparison group of 1,000 similarly aged men will be enrolled in this multi-site observational study from approximately 120 different hospitals across the country. Young women have a much greater risk of dying after an acute myocardial infarction (AMI) than similarly aged men. Their mortality risk is markedly higher than that of young men, and limited data on young minority women suggest that they may have the highest risk of any young subgroup. Findings from the small number of published studies of young women with ischemic heart disease suggest that the biology, epidemiology, care, and outcomes of this group are distinct from those of men. To date, there have been no large studies of this population, even as the death toll is comparable to that from breast cancer in this country. This study will help researchers identify key factors that influence recovery from a heart attack and potentially improve the care and outcomes of young women and men with AMI. *Specific Aims:* To investigate the excess risk in young women with AMI and to identify key demographic, clinical, metabolic, psychosocial, health care delivery, and biological determinants of prognosis, we propose a national, prospective, observational study of 2,000 women who are 55 years or younger with AMI and a smaller comparison group of 1,000 men. Our prior work and preliminary studies indicate that the sex differences are most prominent in this age group and suggest that by 1 year after discharge, there are substantial sex differences in outcomes. We will also develop risk stratification tools that will help clinicians to identify young women with the highest and lowest risk. *Specific Aim 1:* Determine sex differences in outcomes following AMI. *Specific Aim 2:* Determine sex differences in the prevalence and prognostic importance of demographic, clinical, and psychosocial risk factors. * Specific Aim 3:*Determine sex differences in quality of care. *Specific Aim 4:* Determine sex differences in the prevalence and prognostic importance of selected biochemical biomarkers following AMI. *These samples have been whole genome sequenced as part of the NHGRI's Center for Common Disease Genetics at the Broad Institute.*

Link

dbGaP study = phs001259

Palavras-chave

  1. 09/05/2023 09/05/2023 - Simon Heim
Titular dos direitos

Sekar Kathiresan, MD, Broad Institute, Cambridge, MA, USA

Transferido a

9 de maio de 2023

DOI

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Licença

Creative Commons BY 4.0

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dbGaP phs001259 CCDG CVD: VIRGO - Variation in Recover-Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients

Eligibility Criteria

Inclusion and exclusion criteria
Descrição

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*INCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ <ol type="1"> *
Descrição

INCLUSION CRITERIA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
Age 18-55 * *
Descrição

Age 18-55

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001779
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
Descrição

AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C5444992
UMLS CUI [1,3]
C1442837
UMLS CUI [1,4]
C0162490
UMLS CUI [1,5]
C3163633
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
Descrição

Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920210
UMLS CUI [1,2]
C0585642
UMLS CUI [1,3]
C4699980
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
Descrição

CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C1299400
UMLS CUI [1,3]
C0523584
UMLS CUI [1,4]
C0205217
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
Descrição

CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C4699980
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
Descrição

Post-PCI cardiac markers with no pre-existing ACS in the past 24h

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1271630
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1532338
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0521987
UMLS CUI [1,6]
C0948089
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
Descrição

Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0687676
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C1271630
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0521987
UMLS CUI [1,6]
C0027051
UMLS CUI [2,1]
C3887511
UMLS CUI [2,2]
C0151744
Symptoms of ischemia
Descrição

Symptoms of ischemia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0022116
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
Descrição

ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232326
UMLS CUI [1,2]
C0023211
UMLS CUI [1,3]
C0919919
Other evidence of pathological necrosis (imaging, pathology) *
Descrição

Other evidence of pathological necrosis (imaging, pathology) *

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C0027540
Presentation: *Must meet one of the following two criteria:* *
Descrição

Presentation: *Must meet one of the following two criteria:* *

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449450
UMLS CUI [1,2]
C5444992
Patient presented initially at this facility
Descrição

Patient presented initially at this facility

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449976
UMLS CUI [1,2]
C0018704
Patient was transferred here from another facility with 24h of original presentation
Descrição

Patient was transferred here from another facility with 24h of original presentation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030704
UMLS CUI [1,2]
C1554109
UMLS CUI [1,3]
C0018704
*EXCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ **Patients are excluded if any of the following criterion was met:**
Descrição

EXCLUSION CRITERIA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
Patient previously enrolled in VIRGO
Descrição

Patient previously enrolled in VIRGO

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1696073
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0947630
Non-English/non-Spanish speaking
Descrição

Non-English/non-Spanish speaking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1546417
UMLS CUI [2,1]
C1518422
UMLS CUI [2,2]
C0037750
Inability to provide informed consent
Descrição

Inability to provide informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0021430
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
Descrição

Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C5549095
UMLS CUI [1,2]
C1522577
Acute MI due to chest trauma
Descrição

Acute MI due to chest trauma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1337069
Currently a prisoner
Descrição

Currently a prisoner

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0205255
Other reason
Descrição

Other reason

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205394

Similar models

Eligibility Criteria

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
INCLUSION CRITERIA
Item
*INCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ <ol type="1"> *
boolean
C1512693 (UMLS CUI [1,1])
Age 18-55
Item
Age 18-55 * *
boolean
C0001779 (UMLS CUI [1,1])
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
Item
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
boolean
C0155626 (UMLS CUI [1,1])
C5444992 (UMLS CUI [1,2])
C1442837 (UMLS CUI [1,3])
C0162490 (UMLS CUI [1,4])
C3163633 (UMLS CUI [1,5])
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
Item
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
boolean
C0920210 (UMLS CUI [1,1])
C0585642 (UMLS CUI [1,2])
C4699980 (UMLS CUI [1,3])
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
Item
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
boolean
C0201973 (UMLS CUI [1,1])
C1299400 (UMLS CUI [1,2])
C0523584 (UMLS CUI [1,3])
C0205217 (UMLS CUI [1,4])
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
Item
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
boolean
C0201973 (UMLS CUI [1,1])
C4699980 (UMLS CUI [1,2])
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
Item
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
boolean
C1271630 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0521987 (UMLS CUI [1,5])
C0948089 (UMLS CUI [1,6])
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
Item
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
boolean
C0687676 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C1271630 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0521987 (UMLS CUI [1,5])
C0027051 (UMLS CUI [1,6])
C3887511 (UMLS CUI [2,1])
C0151744 (UMLS CUI [2,2])
Symptoms of ischemia
Item
Symptoms of ischemia
boolean
C1457887 (UMLS CUI [1,1])
C0022116 (UMLS CUI [1,2])
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
Item
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
boolean
C0232326 (UMLS CUI [1,1])
C0023211 (UMLS CUI [1,2])
C0919919 (UMLS CUI [1,3])
Other evidence of pathological necrosis (imaging, pathology) *
Item
Other evidence of pathological necrosis (imaging, pathology) *
boolean
C0332120 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0027540 (UMLS CUI [1,3])
Presentation: *Must meet one of the following two criteria:* *
Item
Presentation: *Must meet one of the following two criteria:* *
boolean
C0449450 (UMLS CUI [1,1])
C5444992 (UMLS CUI [1,2])
Patient presented initially at this facility
Item
Patient presented initially at this facility
boolean
C0449976 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Patient was transferred here from another facility with 24h of original presentation
Item
Patient was transferred here from another facility with 24h of original presentation
boolean
C0030704 (UMLS CUI [1,1])
C1554109 (UMLS CUI [1,2])
C0018704 (UMLS CUI [1,3])
EXCLUSION CRITERIA
Item
*EXCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ **Patients are excluded if any of the following criterion was met:**
boolean
C0680251 (UMLS CUI [1,1])
Patient previously enrolled in VIRGO
Item
Patient previously enrolled in VIRGO
boolean
C1696073 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0947630 (UMLS CUI [1,3])
Non-English/non-Spanish speaking
Item
Non-English/non-Spanish speaking
boolean
C1546417 (UMLS CUI [1,1])
C1518422 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Inability to provide informed consent
Item
Inability to provide informed consent
boolean
C1299582 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
Item
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
boolean
C5549095 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Acute MI due to chest trauma
Item
Acute MI due to chest trauma
boolean
C0155626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1337069 (UMLS CUI [1,3])
Currently a prisoner
Item
Currently a prisoner
boolean
C0521116 (UMLS CUI [1,1])
C0205255 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C0205394 (UMLS CUI [1,1])

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