Condition category
Circulatory System
Date applied
03/10/2020
Date assigned
29/10/2020
Last edited
23/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a common lung disease which can flare up, requiring admission to hospital. Patients with COPD often have heart disease, which worsens their symptoms and increase the chances of death and hospital admission. In the short period after a flare-up of COPD, patients are also at a higher risk of heart attacks and irregular heart rhythms, which cause many hospital readmissions and deaths. Unfortunately, heart disease is often not recognised or not treated adequately in patients with COPD. The aim of this study is to test whether carefully finding and treating heart disease in patients admitted to hospital with COPD exacerbation is beneficial.

Who can participate?
Patients admitted to the Trust’s hospitals with an exacerbation of COPD can participate in the study, as long as they are over 35, have a confirmed diagnosis of COPD and do not fulfil any of the exclusion criteria.

What does the study involve?
The researchers will randomly divide participants into two equal groups. One will receive the usual care for exacerbations of COPD. The other group, called the intervention group, will receive this as well as a structured assessment for cardiovascular disease, with the treatment of any diseases identified as recommended in existing local and (inter)national guidelines. The researchers will compare the effect of adding this extra assessment and treatment on the number of days spent alive outside hospital over the subsequent year (this is the primary outcome of the study). The researchers will also measure how markers of strain on the heart change during and after COPD exacerbations in the participants that have the extra tests. Finally, they will assess how participants’ quality of life evolves during the study period, as well as assessing the healthcare services they use and the medications they are prescribed.

What are the possible benefits and risks of participating?
For participants who are assigned to the intervention group, it is hoped that it will be possible to identify heart problems at an early stage so that the right treatment can be started. Although it is not yet known for certain whether early identification and treatment of heart problems will have a positive impact on health, the researchers believe that it will. Participants assigned to the usual care group will still receive high quality, evidence-based care and will be help improve the treatment and prevention of COPD exacerbations. It is hoped that this will benefit other patients with COPD in future, and it may benefit the participants directly.

Where is the study run from?
Northumbria Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2020 to February 2023

Who is funding the study?
1. Chiesi Limited (UK)
2. Northumbria Healthcare NHS Foundation Trust (UK)

Who is the main contact?
1. Dr John Steer
John.Steer@northumbria-healthcare.nhs.uk
2. Dr Joe Kibbler
joseph.kibbler@northumbria-healthcare.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Steer

ORCID ID

http://orcid.org/0000-0003-4415-8814

Contact details

Dept. Respiratory Medicine
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 293 4351
John.Steer@northumbria-healthcare.nhs.uk

Type

Scientific

Additional contact

Dr Joseph Kibbler

ORCID ID

Contact details

Dept. Respiratory Medicine
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 293 4351
joseph.kibbler@northumbria-healthcare.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 47350, IRAS 277817

Study information

Scientific title

Structured cardiac assessment and treatment following exacerbations of chronic obstructive pulmonary disease: a pilot randomised controlled trial

Acronym

SCATECOPD

Study hypothesis

A comprehensive, structured cardiovascular assessment, with treatment of problems identified, increases the time patients spend alive outside of hospital following hospital admission for a COPD exacerbation.

Ethics approval

Approval pending

Study design

Single-centre pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Identification of cardiovascular disease (CVD) in patients admitted to hospital with COPD exacerbations.

Intervention

Participants will be randomized to receive usual care for COPD exacerbation, or to receive usual care plus structured assessment for cardiovascular disease. Stratified randomisation by the presence of known cardiovascular disease and PEARL score (a validated method of predicting the likelihood of readmission with COPD exacerbation) will be used.

Cardiovascular disease identified by the structured assessment will be treated according to current UK standard care in keeping with local and/or national guidance. The intervention is a detailed cardiovascular assessment: transthoracic echocardiography, cardiac biomarker assessment, 24-h cardiac monitoring, CT coronary artery calcification quantification, and assessment for hypertension. Treatment of identified cardiovascular disease will be in line with current local and/or national guidance and will be led by the usual care team.

Participants will be reviewed clinically 90 days and 12 months following hospital discharge. All will undergo a clinical assessment, spirometry, quality of life questionnaires, assessment of walking speed, and an assessment of health resource use. At 90 days, those in the intervention arm will have repeat electrocardiography, transthoracic echocardiography and cardiac biomarker measurements. Participants will also be contacted by telephone at 6 and 9 months after discharge to gather information about their medication use and interaction with healthcare services.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The number of days spent alive outside of a hospital environment, measured using electronic hospital records during 12 months post hospital discharge

Secondary outcome measures

1. Time to readmission or death following hospital admission for ECOPD, collected from hospital health records using Patient Administration System (PAS)
2. All-cause readmission rates at 90 days and 12 months post discharge, collected from hospital health records using Patient Administration System (PAS)
3. All-cause mortality rates at 90 days and 12 months post discharge, collected from hospital health records using Patient Administration System (PAS)
4. COPD exacerbation rates, from health records and self-report, at 90 days and 12 months
5. Rates of adverse cardiovascular events (nonfatal stroke or myocardial infarction, and cardiovascular death) at 90 days and 12 months post discharge
6. Rate of new diagnosis of cardiovascular disease at 90 days and 12 months
7. Rate of undertreated cardiovascular disease at baseline, 90 days and 12 months
8. Change in 4-m gait speed at 90 days and 12 months, compared to baseline
9. Mean change in quality of life measured by St. Georges' Respiratory Questionnaire over 12 months
10. Health costs and estimated Quality-Adjusted Life Years (QALY), measured by health records and patient-completed resource utilisation proforma, at 12 months

In the intervention arm the researchers will also report as secondary outcomes:
11. Changes in right heart function (estimated pulmonary artery systolic pressure [PASP] and tricuspid annular plane systolic excursion [TAPSE] measured by echocardiography) between baseline and 90 days
12. Relationship between changes in right heart function (estimated pulmonary artery systolic pressure [PASP] and tricuspid annular plane systolic excursion [TAPSE] measured by echocardiography) and ECOPD severity measured using DECAF score at admission and 90 days
13. Relationship between changes in right heart function (estimated pulmonary artery systolic pressure [PASP] and tricuspid annular plane systolic excursion [TAPSE] measured by echocardiography) and comorbid CVD at admission and 90 days
14. Relationship between right heart function (estimated pulmonary artery systolic pressure [PASP] and tricuspid annular plane systolic excursion [TAPSE] measured by echocardiography) and COPD severity at baseline
15. The associations between the primary outcome and right heart function (estimated pulmonary artery systolic pressure [PASP] and tricuspid annular plane systolic excursion [TAPSE] measured by echocardiography) at baseline

Overall trial start date

01/09/2020

Overall trial end date

28/02/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age >35 years
2. Current/former smoker & smoking burden >10 pack-years
3. Clinical diagnosis of COPD, supported by previous obstructive spirometry
4. Admission to hospital with the primary cause being an exacerbation of COPD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Reason for admission not ECOPD in view of attending clinical team
2. Unable to provide informed consent
3. Any non-COPD condition likely to limit survival to less than 12 months
4. Contraindication to non contrast CT scan
5. Pregnancy or breastfeeding

Recruitment start date

30/11/2020

Recruitment end date

28/02/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Tyneside General Hospital
Northumbria Healthcare NHS Foundation Trust Rake Lane
North Shields, Tyne and Wear
NE29 8NH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Research and Development
Education Centre
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 293 4087
researchanddevelopment@nhct.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.northumbria.nhs.uk/

Funders

Funder type

Industry

Funder name

Chiesi Farmaceutici

Alternative name(s)

Chiesi Pharmaceuticals, Chiesi

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

Italy

Funder name

Northumbria Healthcare NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers plan to present preliminary results at an international conference at the end of 2022 / early 2023 with the publication of the main paper in a leading peer-reviewed journal towards the end of 2023.

IPD sharing statement
Anonymised participant-level data can be shared after the main results have been published. Applications should be made to the Trial Steering Committee who will consider all requests.

Intention to publish date

01/10/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: The recruitment start date was changed from 16/11/2020 to 30/11/2020. 05/11/2020: Uploaded protocol (not peer reviewed) Version 1 01 September 2020. 06/10/2020: Trial's existence confirmed by Northumbria Healthcare NHS Foundation Trust.