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Trial record 11 of 6671 for:    senior citizens

Assessing Frailty in Elderly Patients Who Have Ischemic Heart Disease (FRAIL_HEART)

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ClinicalTrials.gov Identifier: NCT04019405
Recruitment Status : Active, not recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hull and East Yorkshire Hospitals NHS Trust

Brief Summary:
Participants aged 80 years or over, who attend Castle Hill Hospital with either stable angina or an acute coronary syndrome will be invited to participate in the study. After induction into the study, these participants will be assessed for frailty and quality of life (QoL) using predetermined assessment tools. Quality of life (QoL) will be assessed using the standardised SF-12 questionnaire proforma. Frailty assessment will be based on the use of the Fried Frailty Phenotype criteria and the Edmonton Frailty Scale. Patients will be reassessed at 3,9 and 24 months for their clinical outcomes, repeat frailty assessment and quality of life.

Condition or disease
Frail Elderly

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Frailty in Elderly People With Ischemic Heart Disease Being Considered for Revascularisation.
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Frailty status
Frailty status will be determined by prespecified assessment tools in the study protocol. These assessment tools will be Fried Frailty phenotype model and edmonton frailty Scale.



Primary Outcome Measures :
  1. Change in Quality Of Life Questionnaire [ Time Frame: baseline and 3, 9 and 24 months ]
    The primary out come will be quality of life assessed by SF-12 survey forms


Secondary Outcome Measures :
  1. Change in frailty Status - Fried frailty Criteria [ Time Frame: baseline and 3, 9 and 24 months ]
    To evaluate changes in frailty using the Fried frailty criteria.

  2. Change in frailty Status - Edmonton Frailty Score [ Time Frame: baseline and 3, 9 and 24 months ]
    To evaluate changes in frailty using the Edmonton frailty score.

  3. Major adverse clinical events during hospitalization [ Time Frame: baseline and 3, 9 and 24 months ]
    To evaluate major adverse clinical event (MACE) (defined as a composite of death, acute myocardial infarction, acute cerebrovascular event (CVA), and major bleeding) occurring during hospitalisation for frail versus non-frail participants of study.

  4. Major Adverse Clinical Event [ Time Frame: 24 months ]
    To evaluate major adverse clinical event (MACE) (defined as a composite of death, acute myocardial infarction, acute cerebrovascular event (CVA), major bleeding, and unplanned rehospitalisation occurring at 24 months follow-up for frail versus non-frail participants of the study.

  5. Predictors of adverse outcome [ Time Frame: baseline and 3, 9 and 24 months ]
    Patients' variables will be evaluated to determine the independent predictors of an adverse outcome (defined as death or a worsening in QOL at follow-up).



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients (male and female) aged 80 and over and who have a primary diagnosis of ischaemic heart disease will be eligible for participation in the study.
Criteria

Inclusion Criteria:

Aged 80 years and above and either

  1. Have been seen in the cardiology out-patient department with a diagnosis of stable angina
  2. Have been admitted to Castle Hill Hospital with non-ST elevation acute myocardial infarction (NSTEMI)
  3. Have been admitted to Castle Hill Hospital with ST-elevation acute myocardial infarction (STEMI)
  4. Have been referred to Castle Hill Hospital for coronary angioplasty
  5. Have been referred to Castle Hill Hospital for coronary artery bypass graft surgery

Exclusion Criteria:

Patients will be excluded from the study in the event of any of the following:

  1. Patients who are unable to provide informed consent including those with advanced dementia.
  2. Patients, who are not able to speak good English sufficiently to be able to understand the study information, give consent and complete study measures.
  3. Patients who have a primary diagnosis of significant valvular disease

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): NCT04019405


Locations
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United Kingdom
Castle Hill Hospital
Cottingham, East Riding Of Yorkshire NHS Trust, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
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Principal Investigator: Angela Hoye, MB.ChB,PhD Hull and East Yorkshire NHS Trust

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Responsible Party: Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04019405     History of Changes
Other Study ID Numbers: 193997
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data will not be shared

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
coronary artery disease
elderly
revascularisation
frailty

Additional relevant MeSH terms:
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Heart Diseases
Frailty
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases