Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients - VIRGO

Study ID
STU 102010-101

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Griselda Soto
214-648-7630
griselda.soto@utsouthwestern.edu

Principal Investigator
Amit Khera

Summary

About 200 people will take part in this study at UT Southwestern or Parkland Health & Hospital System. This study also is taking place at about 120 medical facilities around the country. There will be a total of about 2,000 women and 1,000 young men between the ages of 18 and 55 years old participating in this research study thoughout the United States. Because the prevalence of Acute Myocardial Infaraction (AMI) is higher among young men, we will be using a systematic screening and enrollment strategy to ensure that the 2:1 female to male ratio at each site is maintained. The stategy may be modified however, during the study to ensure the proper ratio is achieved.

Participant Eligibility

Inclusion Criteria:
1. Age 18 x 55
2. 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 within 24 hours of admission:

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

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

* CK value on the same draw or CK-MB mass greater than the 99th percentile of URL

Do NOT include the following:

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

* Post-CABG cardiac markers with no pre-existing AMI

2.2. Supporting evidence of myocardial ischemia with at least one of the following:

* Symptoms of ischemia

* ECG changes indicative of new ischemia - if yes, check appropriate box(es) below:

* if yes, check appropriate box(es) below:

* New ST-T changes

* New or presumably new left bundle branch block (LBBB)

* Development of pathological Q waves

* Other evidence of myocardial necrosis (imaging, pathology) (Describe):

3. Presentation

* Patient presented initially at this facility

* Patient was transferred here from another facility within 24 hours of original presentation