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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.
 
ClinicalTrials.gov Identifier: NCT01755052
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

Study Description
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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.


Condition or disease
Acute Myocardial Infarction

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.

Study Design
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Study Type : Observational
Actual Enrollment : 3042 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction
Study Start Date : January 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All-cause hospital readmission [ Time Frame: up to six months ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to six months ]
  2. Decline in health status [ Time Frame: up to six months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

    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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755052


Locations
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Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sarwat Chaudhry, MD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01755052    
Other Study ID Numbers: 1205010311
1R01HL115295-01 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Acute Myocardial Infarction
Geriatrics
Cardiology
Aging
 Heart Attack
Risk Factors
Quality of Care
Risk Models
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases