SILVER-AMI: Outcomes in Older Persons With Heart Attacks

Acute Myocardial Infarction Clinical Trial

— SILVER-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755052
• Other study ID #: 1205010311
• Secondary ID: 1R01HL115295-01
• Status: Completed
• Start date: January 2013
• Est. completion date: June 2018

Study information

• Verified date: May 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3042
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	Mission Medical Associates, Inc. dba Asheville Cardiology Associates	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital, Inc.	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Advanced Heart Care, LLC	Bridgewater	New Jersey
United States	Montefiore/Albert Einstein Medical Center	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The University Of Chicago	Chicago	Illinois
United States	Metropolitan Cardiology Consultants	Coon Rapids	Minnesota
United States	Good Samaritan Hospital, Corvallis	Corvallis	Oregon
United States	The Danbury Hospital and the Western Connecticut Medical	Danbury	Connecticut
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Denver Health Medical Center	Denver	Colorado
United States	Iowa Heart Center	Des Moines	Iowa
United States	St. John Hospital & Medical Center	Detroit	Michigan
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Northshore University Health System	Evanston	Illinois
United States	Sanford Research	Fargo	North Dakota
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Bellin Memorial Hospital, Inc.	Green Bay	Wisconsin
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Meritus Medical Center	Hagerstown	Maryland
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	St Mary's Medical Center	Huntington	West Virginia
United States	St. Francis Medical Group	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Mid America Heart Institute St. Luke's Hospital	Kansas City	Missouri
United States	Nebraska Specialty Network	Lincoln	Nebraska
United States	Los Alamitos Internal Medical Group	Los Alamitos	California
United States	Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	The Corporation of Mercer University	Macon	Georgia
United States	Aurora Research Institute	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	The International Heart Institute of Montana	Missoula	Montana
United States	Yale University	New Haven	Connecticut
United States	New York University School of Medicine	New York	New York
United States	The Trustees of Columbia University in the City of New York	New York	New York
United States	Sentara Hospital	Norfolk	Virginia
United States	McLaren Cardiovascular Group	Okemos	Michigan
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	CHI-Health-Alegent Creighton Research	Omaha	Nebraska
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	OHSU: Oregon Health & Science University	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon
United States	Providence Health & Services	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Rapid City Regional Hospital, Inc.	Rapid City	South Dakota
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Francis Research & Educational Corporation	Roslyn	New York
United States	Mercy General Hospital	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Donald Guthrie Foundation for Education and Research	Sayre	Pennsylvania
United States	Cox Health	Springfield	Missouri
United States	St. Joseph's Medical Center	Stockton	California
United States	The Research Foundation for the State University of New York	Stony Brook	New York
United States	Overlook Medical Center	Summit	New Jersey
United States	Florida Hospital Pepin Heart Institute	Tampa	Florida
United States	Torrance Memorial Medical Center	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	South Georgia Medical Center	Valdosta	Georgia
United States	Providence Healthcare Network	Waco	Texas
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause hospital readmission		up to six months
Secondary	All-cause mortality		Up to six months
Secondary	Decline in health status		up to six months