SILVER-AMI: Outcomes in Older Persons With Heart Attacks



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:75 - Any
Updated:1/19/2018
Start Date:January 2013
End Date:June 2018

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SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

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.

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.

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)
We found this trial at
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Chapel Hill, North Carolina 27599
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