SILVER-AMI: Outcomes in Older Persons With Heart Attacks

NCT ID: NCT01755052

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3042 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarwat Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Los Alamitos Internal Medical Group

Los Alamitos, California, United States

Mercy General Hospital

Sacramento, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

St. Joseph's Medical Center

Stockton, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

University of Colorado

Aurora, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

The Danbury Hospital and the Western Connecticut Medical

Danbury, Connecticut, United States

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Florida Hospital Pepin Heart Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

The Corporation of Mercer University

Macon, Georgia, United States

South Georgia Medical Center

Valdosta, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, 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

Northshore University Health System

Evanston, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

St. Francis Medical Group

Indianapolis, Indiana, United States

Iowa Heart Center

Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, United States

Meritus Medical Center

Hagerstown, Maryland, United States

Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

St. John Hospital & Medical Center

Detroit, Michigan, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

McLaren Cardiovascular Group

Okemos, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mid America Heart Institute St. Luke's Hospital

Kansas City, Missouri, United States

Cox Health

Springfield, Missouri, United States

Washington University

St Louis, Missouri, United States

The International Heart Institute of Montana

Missoula, Montana, United States

Nebraska Specialty Network

Lincoln, Nebraska, United States

CHI-Health-Alegent Creighton Research

Omaha, Nebraska, United States

Advanced Heart Care, LLC

Bridgewater, New Jersey, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Overlook Medical Center

Summit, New Jersey, United States

Presbyterian Heart Group

Albuquerque, New Mexico, 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

St. Francis Research & Educational Corporation

Roslyn, New York, United States

The Research Foundation for the State University of New York

Stony Brook, New York, United States

Montefiore/Albert Einstein Medical Center

The Bronx, New York, United States

Mission Medical Associates, Inc. dba Asheville Cardiology Associates

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Research

Fargo, North Dakota, United States

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

Good Samaritan Hospital, Corvallis

Corvallis, Oregon, United States

Providence Health & Services

Portland, Oregon, United States

OHSU: Oregon Health & Science University

Portland, Oregon, United States

Portland VA Medical Center

Portland, Oregon, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, United States

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Rapid City Regional Hospital, Inc.

Rapid City, South Dakota, United States

Providence Healthcare Network

Waco, Texas, United States

Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Sentara Hospital

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

St Mary's Medical Center

Huntington, West Virginia, United States

Bellin Memorial Hospital, Inc.

Green Bay, Wisconsin, United States

Aurora Research Institute

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31816630 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31010300 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25370536 (View on PubMed)

Other Identifiers

1R01HL115295-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1205010311

Identifier Type: -

Identifier Source: org_study_id