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Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488536
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Niklas Ekerstad, Linkoeping University

Brief Summary:

Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are usually (>90%) offered an early invasive strategy including coronary angiography possibly followed by intervention, preferably percutaneous coronary intervention (PCI). Among non ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only approximately 40% receive an invasive approach in Sweden, since the majority are handled in a conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological treatment, there is a large variation between Swedish counties regarding the choice of strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger variation between acute hospitals ranging from 20% to 90 %.

The Swedish national guidelines for heart disease have emphasized that the patient's biological age, i.e. the patient's biological status and expected length of life, is crucial for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment. The investigators have previously reported the potential importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of frailty´s prognostic value, its capacity to predict adverse effects including complications, and the potential to guide clinical decision-making for elderly patients with myocardial infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of comorbidity burden might influence rational decision-making.

Aims To explore the association between frailty and treatment patterns in cardiac care To study the association between outcomes and degree of frailty, with and without comprehensive adjustment for differences in baseline characteristics.

To study how treatment benefits for patients admitted to coronary care units differ in patients depending on comorbidities and frailty.

Hypothesis The investigators hypothesize that frailty is independently associated with worse outcomes, including mortality, readmissions and complications.

Methods and material An observational, register based, multicentre study. Inclusion criteria: Patients consecutively included in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. Exclusion criteria: None.

SWEDEHEART is a national quality registry collecting information on all patients hospitalized with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with data. Briefly, information is collected prospectively about individual patients' medical history, treatment before admission, management during hospital stay, treatment at discharge, and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry. However, as a pilot project to ensure feasibility, five hospitals began to register frailty November 1st, 2017. For the investigators initial analyses data will be used from the pilot study to assess the association between CFS level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART registry. After about two years the investigators will extract data prospectively entered into the registry.

The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good predictive validity and prognostic power, is relying on clinical judgment, and is relatively easily used in clinical practice. Since the scale includes several degrees it can be considered to be particularly appropriate for risk stratification, and accordingly it has been used for this purpose. The investigators have got the instrument owner´s permission to use this scale.

The case record form (CRF) focus on demographic and clinical patient characteristics registered in the SWEDEHEART, particularly those which are supposed to be potential confounders when testing the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory testing and registration of anthropometric data will be included according to routine practice within the frame of SWEDEHEART.

Follow-up of cohorts of invasively or conservatively treated patients with different stages of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point respectively.


Condition or disease Intervention/treatment
Myocardial Infarction Frailty Diagnostic Test: Clinical Frailty Scale

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
Frail patients
Clinical Frailty Scale level 5-9
Diagnostic Test: Clinical Frailty Scale
Frailty assessment

Nonfrail patients
Clinical Frailty Scale level 1-4
Diagnostic Test: Clinical Frailty Scale
Frailty assessment




Primary Outcome Measures :
  1. Mortality rate by 6 months after inclusion. [ Time Frame: 6 months after inclusion ]
    Mortality rate (death from any cause) by 6 months after inclusion.


Secondary Outcome Measures :
  1. Mortality rates up to 36 months after inclusion. [ Time Frame: 3-36 months after inclusion ]
    Mortality rates (death from any cause) up to 36 months after inclusion (measured at 3, 12, 24, 36 months)

  2. Rates of readmissions and complications up to 36 months after inclusion. [ Time Frame: 3-36 months after inclusion ]
    Rates of readmissions, re-infarctions, major bleedings and other complications up to 36 months after inclusion (measured at 3, 12, 24, 36 months)

  3. Description of treatment patterns including medications and invasive strategies from admission to hospital (inclusion) to discharge from hospital (index care hospital episode) [ Time Frame: From admission to hospital (inclusion) up to 36 months after inclusion ]
    Percentage (%) of patients receiving evidence based medications during the index care hospital episode Percentage (%) of patients receiving evidence based interventions during the index care hospital episode



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SWEDEHEART is a national quality registry, which collects information on all patients hospitalized with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with data. From January 1st 2020 Clinical Frailty Scale, the 9-degree-version (CFS-9) is a mandatory variable in the registry. However, as a pilot project to ensure feasibility, five hospitals began to register frailty November 1st, 2017. Inclusion criteria: patients consecutively included in the SWEDEHEART registry from November 1, 2017. Exklusion criteria: none.
Criteria

Inclusion Criteria:

  • Patients consecutively included in the SWEDEHEART registry from November 1, 2017.

Exclusion Criteria:

  • None.

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): NCT04488536


Contacts
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Contact: Niklas Ekerstad, MD, PhD +46 (0)736249652 niklas.ekerstad@liu.se
Contact: Joakim Alfredsson, MD, PhD +46 (0)709620905 joakim.alfredsson@liu.se

Locations
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Sweden
The Center for Medical Technology Assessment/IMH, Linkoeping University Recruiting
Linköping, Oestergoetland, Sweden, 58183
Principal Investigator: Niklas G Ekerstad, MD         
Linkoeping University Hospital Recruiting
Linköping, Ostergoetland, Sweden
Contact: Niklas Ekerstad, MD, PhD       niklas.ekerstad@liu.se   
Contact: Joakim Alfredsson, MD, PhD       joakim.alfredsson@liu.se   
Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Niklas Ekerstad, MD, PhD Linkoeping University
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Responsible Party: Niklas Ekerstad, Associate professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT04488536    
Other Study ID Numbers: 2020-01708
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Niklas Ekerstad, Linkoeping University:
Myocardial infarction
Frailty assessment
Clinical Frailty Scale
Predictive power
Mortality
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Frailty
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases