SILVER-AMI: Outcomes in Older Persons With Heart Attacks

Yale University

Status: Completed

Conditions: Acute Myocardial Infarction

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01755052

1R01HL115295-01 (U.S. NIH Grant/Contract)

1205010311

Details and patient eligibility

About

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons.

The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.

Full description

The overall objective of this study is to develop and validate risk stratification tools for older adults who have recently had an Acute Myocardial Infarction (AMI). While there is emerging interest in understanding the role of geriatric conditions as they pertain to cardiovascular outcomes, there is no standard, feasible assessment of older patients with AMI that can stratify their risk of subsequent morbidity and mortality. Currently available risk models are designed solely to predict clinical events (e.g. mortality, reinfarction). This is insufficient for shared decision making with older patients, who consistently rate maintenance of favorable health status as a top priority. This study will address these gaps by melding principles from geriatrics and cardiology to create post-AMI risk models specifically designed for older patients. This study is significant because older persons with AMI are a growing, yet understudied, population.

Dr. Sarwat Chaudhry at Yale University is conducting a multi-center, observational study designed to collect data about the post-AMI recovery period that will be used to generate risk models for older patients with AMI. The intent of the study is to use the knowledge from the data collected in SILVER-AMI to ultimately design interventions to improve the care and outcomes of older patients with AMI.

Study coordinators will screen older patients hospitalized with an AMI. Participants will be assessed at baseline prior to AMI hospital discharge through an interview, physical assessment and medical record review. One follow-up interview will be conducted approximately 6 months later by the Yale Follow-up Center. Clinical outcomes will be assessed for the follow-up period occurring 6 months post AMI hospitalization through self-report and medical record review.

Enrollment: 3,042 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥75 years upon admission to the hospital

2. Elevation of cardiac markers within 24 hours of presentation to the hospital

   a. Troponin must rise above the upper limit of normal established by the hospital as a determinate of cardiac injury.

3. Any one of the following:

   1. Symptoms of ischemia
   2. ECG with ischemic changes
   3. Imaging evidence of Infarction
   4. Intracoronary thrombus on angiography

Exclusion criteria

1. Patient transferred from another hospital with a length of stay >48 hours at the referring hospital.
2. Refused Informed Consent
3. Decisional impairment with no legally authorized representative
4. AMI is secondary to chest trauma
5. AMI is secondary to in-patient procedure or surgery
6. History of heart transplant
7. Non-English/Non-Spanish speaking
8. Inability to complete interview (e.g. comatose or aphasia)
9. Inability to contact for follow-up (e.g. no access to phone, not living in the country)
10. Currently a prisoner
11. Death prior to enrollment
12. Previously enrolled in SILVER-AMI
13. Troponin elevation is the result of apical ballooning syndrome (i.e., Takotsubo)