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SILVER-AMI: Outcomes in Older Persons With Heart Attacks

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sarwat Chaudhry, Yale University
ClinicalTrials.gov Identifier:
NCT01755052
First received: November 27, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • All-cause hospital readmission [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
  • Decline in health status [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3100
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Older adults admitted to the hospital with a heart attack

Criteria

Inclusion Criteria:

  1. Age ≥75 years upon admission to the hospital
  2. Elevation of cardiac markers within 24 hours of presentation to the hospital

  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 >24 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755052

  Show 38 Study Locations
Sponsors and Collaborators
Sarwat Chaudhry
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sarwat Chaudhry, MD Yale University
  More Information

No publications provided

Responsible Party: Sarwat Chaudhry, Principal Investigator, Coordinating Center, Yale University
ClinicalTrials.gov Identifier: NCT01755052     History of Changes
Other Study ID Numbers: GRANT10974014, 1R01HL115295-01
Study First Received: November 27, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Acute Myocardial Infarction
Geriatrics
Cardiology
Aging
 Heart Attack
Risk Factors
Quality of Care
Risk Models

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013