Clinical trial NCT01755052: SILVER-AMI: Outcomes in Older Persons With Heart Attacks
Official title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Geriatrics
Cardiology
Aging
Heart Attack
Risk Factors
Quality of Care
Risk Models
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-12-21
Enrollment: 3042
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults admitted to the hospital with a heart attack

Brief summary: 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.

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 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

   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)

Primary outcomes:
measure: All-cause hospital readmission
timeFrame: up to six months
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to six months
measure: Decline in health status
timeFrame: up to six months
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Los Alamitos
country: United States
facility: Los Alamitos Internal Medical Group
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Danbury
country: United States
facility: The Danbury Hospital and the Western Connecticut Medical
state: Connecticut
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Tampa
country: United States
facility: Florida Hospital Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Macon
country: United States
facility: The Corporation of Mercer University
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University Of Chicago
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Francis Medical Group
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Hagerstown
country: United States
facility: Meritus Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Okemos
country: United States
facility: McLaren Cardiovascular Group
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Cardiology Consultants
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Missoula
country: United States
facility: The International Heart Institute of Montana
state: Montana
city: Lincoln
country: United States
facility: Nebraska Specialty Network
state: Nebraska
city: Omaha
country: United States
facility: CHI-Health-Alegent Creighton Research
state: Nebraska
city: Bridgewater
country: United States
facility: Advanced Heart Care, LLC
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bronx
country: United States
facility: Montefiore/Albert Einstein Medical Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: The Trustees of Columbia University in the City of New York
state: New York
city: Roslyn
country: United States
facility: St. Francis Research & Educational Corporation
state: New York
city: Stony Brook
country: United States
facility: The Research Foundation for the State University of New York
state: New York
city: Asheville
country: United States
facility: Mission Medical Associates, Inc. dba Asheville Cardiology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research
state: North Dakota
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Corvallis
country: United States
facility: Good Samaritan Hospital, Corvallis
state: Oregon
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Portland
country: United States
facility: OHSU: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Rapid City
country: United States
facility: Rapid City Regional Hospital, Inc.
state: South Dakota
city: Waco
country: United States
facility: Providence Healthcare Network
state: Texas
city: Lynchburg
country: United States
facility: Stroobants Cardiovascular Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Huntington
country: United States
facility: St Mary's Medical Center
state: West Virginia
city: Green Bay
country: United States
facility: Bellin Memorial Hospital, Inc.
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
Study officials:
affiliation: Yale University
name: Sarwat Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodson JA, Hajduk AM, Geda M, Krumholz HM, Murphy TE, Tsang S, Tinetti ME, Nanna MG, McNamara R, Gill TM, Chaudhry SI. Predicting 6-Month Mortality for Older Adults Hospitalized With Acute Myocardial Infarction: A Cohort Study. Ann Intern Med. 2020 Jan 7;172(1):12-21. doi: 10.7326/M19-0974. Epub 2019 Dec 10.
citation: Dodson JA, Hajduk AM, Murphy TE, Geda M, Krumholz HM, Tsang S, Nanna MG, Tinetti ME, Goldstein D, Forman DE, Alexander KP, Gill TM, Chaudhry SI. Thirty-Day Readmission Risk Model for Older Adults Hospitalized With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005320. doi: 10.1161/CIRCOUTCOMES.118.005320.
citation: 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.