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
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|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|
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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).
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
|Castle Hill Hospital|
|Cottingham, East Riding Of Yorkshire NHS Trust, United Kingdom, HU16 5JQ|
|Principal Investigator:||Angela Hoye, MB.ChB,PhD||Hull and East Yorkshire NHS Trust|