Assessing Frailty in Elderly Patients Who Have Ischemic Heart Disease

NCT04019405 | Completed

• 1 other identifier: 193997
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly

Keywords

coronary artery disease; elderly; revascularisation; frailty

Outcome Measures

Primary Outcomes (1)

• Change in Quality Of Life Questionnaire

  The primary out come will be quality of life assessed by SF-12 survey forms

  baseline and 3, 9 and 24 months

Secondary Outcomes (5)

• Change in frailty Status - Fried frailty Criteria

  baseline and 3, 9 and 24 months

• Change in frailty Status - Edmonton Frailty Score

  baseline and 3, 9 and 24 months

• Major adverse clinical events during hospitalization

  baseline and 3, 9 and 24 months

• Major Adverse Clinical Event

  24 months

• Predictors of adverse outcome

  baseline and 3, 9 and 24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Aged 80 years and above and either
• Have been seen in the cardiology out-patient department with a diagnosis of stable angina
• Have been admitted to Castle Hill Hospital with non-ST elevation acute myocardial infarction (NSTEMI)
• Have been admitted to Castle Hill Hospital with ST-elevation acute myocardial infarction (STEMI)
• Have been referred to Castle Hill Hospital for coronary angioplasty
• Have been referred to Castle Hill Hospital for coronary artery bypass graft surgery

You may not qualify if:

• Patients will be excluded from the study in the event of any of the following:
• Patients who are unable to provide informed consent including those with advanced dementia.
• Patients, who are not able to speak good English sufficiently to be able to understand the study information, give consent and complete study measures.
• Patients who have a primary diagnosis of significant valvular disease

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Cottingham, East Riding of Yorkshire NHS Trust, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Frailty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Hoye, MB.ChB,PhD

  Hull and East Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: July 15, 2019
• Study Start: July 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)