SILVER-AMI: Outcomes in Older Persons With Heart Attacks (SILVER-AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755052
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : January 17, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

November 27, 2012
December 21, 2012
January 17, 2018
January 2013
June 2018   (Final data collection date for primary outcome measure)
All-cause hospital readmission [ Time Frame: up to six months ]
Same as current
Complete list of historical versions of study NCT01755052 on Archive Site
  • All-cause mortality [ Time Frame: Up to six months ]
  • Decline in health status [ Time Frame: up to six months ]
Same as current
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SILVER-AMI: Outcomes in Older Persons With Heart Attacks
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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Older adults admitted to the hospital with a heart attack
Acute Myocardial Infarction
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Dodson JA, Geda M, Krumholz HM, Lorenze N, Murphy TE, Allore HG, Charpentier P, Tsang SW, Acampora D, Tinetti ME, Gill TM, Chaudhry SI. Design and rationale of the comprehensive evaluation of risk factors in older patients with AMI (SILVER-AMI) study. BMC Health Serv Res. 2014 Nov 5;14:506. doi: 10.1186/s12913-014-0506-4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
June 2018
June 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
75 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R01HL115295-01 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Yale University
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Sarwat Chaudhry, MD Yale University
Yale University
January 2018