Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000200785
Ethics application status
Not yet submitted
Date submitted
28/01/2013
Date registered
19/02/2013
Date last updated
1/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Safe and effective early discharge of patients with low-risk coronary artery disease
Scientific title
In patients with low-risk acute coronary syndromes who undergo angioplasty and stenting, or medical therapy after coronary angiography, is early discharge (<72 hours) to ambulatory care as safe as conventional 4-5 day hospital stay with no increase in mortality, adverse events or unexpected readmission to hospital?
Secondary ID [1] 281850 0
Nil
Universal Trial Number (UTN)
U1111-1138-9754
Trial acronym
SEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic heart disease 288213 0
Condition category
Condition code
Cardiovascular 288578 288578 0 0
Coronary heart disease
Public Health 288764 288764 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early hospital discharge to ambulatory care with nursing follow up. Subjects in the this group will be discharged within 72 hours of admission to ambulatory care with daily home visit by the nursing staff for a minimum of 3 days up to a week. Subjects’ blood pressure, heart rate and ECG will be recorded at each visit and further cardiac education will be offered.
Intervention code [1] 286409 0
Treatment: Other
Comparator / control treatment
Conventional 4-5 day hospital stay with no added nursing intervention
Control group
Active

Outcomes
Primary outcome [1] 288732 0
All cause mortality and major cardiac adverse events (MACE)
Timepoint [1] 288732 0
30 day
Primary outcome [2] 288733 0
Readmission for any of congestive heart failure, unstable angina, arrhythmia, re-infarction, and/or revascularization
Timepoint [2] 288733 0
30 day
Primary outcome [3] 288734 0
Non-cardiac complications such as major bleeding, stroke, acute renal impairment and stroke
Timepoint [3] 288734 0
30 day
Secondary outcome [1] 300856 0
Health-related quality of life as measured by EQ-5D and Seattle Angina questionnaires
Timepoint [1] 300856 0
6 weeks and 3 months
Secondary outcome [2] 300857 0
Patients’ experiences of in-patient care will be evaluated using the Picker Patient Experience Questionnaire
Timepoint [2] 300857 0
At time of discharge from either ambulatory care or hospital
Secondary outcome [3] 300858 0
Compliance with medications will be assessed via phone interview using Morisky 8-Item Medication Adherence Questionnaire
Timepoint [3] 300858 0
6 weeks and 3 months
Secondary outcome [4] 300859 0
Compliance with smoking cessation
Subjects will be asked about their current smoking status via phone interview.
Timepoint [4] 300859 0
6 weeks and 3 months
Secondary outcome [5] 300860 0
Attendance at cardiac rehabilitation session
Timepoint [5] 300860 0
6 weeks and 3 months
Secondary outcome [6] 300861 0
Cost-effectiveness
This will be assessed by comparing the total costs in both intervention group (reduced hospital length of stay and cost of ambulatory care) and control group (costs of conventional in-patient stay)
Timepoint [6] 300861 0
3 months
Secondary outcome [7] 300862 0
Feasibility of the module of ambulatory care.
The study will be considered feasible if >80% of patients in the intervention group are discharged within 72 hours, and >80% of patients are followed up by ambulatory care nurse for a minimum of 3 days
Timepoint [7] 300862 0
3 months

Eligibility
Key inclusion criteria
Participants who suffer from heart attacks, over 18 years of age and are willing and able to sign informed consent forms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years

Pregnant

Non-English speaking background patient without English speaking carer.

Significant medical co-morbidities such as severe COPD, pre-existing heart failure, poorly controlled diabetes, and moderate to severe renal impairment

Lesions that require further revascularization (ie. Staged PCI or CABG)

Other lesions that have >70% intra-luminal stenosis on coronary angiogram and are managed medically

Ejection Fraction <40%

Out of hospital cardiac arrest requiring >3 x DCRs, intubation or inotropic support

Unsuccessful or complicated PCI such as no reflow, temporary pacing and perforation.

Patients who develop non-cardiac complications within 24 hours after PCI: bleeding, stroke, acute renal impairment, vascular sequelae, groin hematoma >5cm diameter, active infection or sepsis

STEMI patients who receive thrombolysis prior to transfer to BHH

Resides >60km radius from Box Hill Hospital

Poor social support and pre-existing significant mobility or memory issue

History of illicit drug use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables will be summarized by means, standard deviations, medians and ranges. Categorical variables will be summarized by frequencies and percentages.

In order to assess comparability of treatment groups, subject demographics and other baseline characteristics will be tabulated separately by treatment group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
28/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 505 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 6247 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 286631 0
Hospital
Name [1] 286631 0
Cardiology Department Eastern Health
Country [1] 286631 0
Australia
Primary sponsor type
Hospital
Name
Cardiology Department Eastern Health
Address
Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria
Country
Australia
Secondary sponsor category [1] 285416 0
None
Name [1] 285416 0
Address [1] 285416 0
Country [1] 285416 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288710 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 288710 0
Ethics committee country [1] 288710 0
Australia
Date submitted for ethics approval [1] 288710 0
01/02/2013
Approval date [1] 288710 0
Ethics approval number [1] 288710 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37382 0
A/Prof Gishel New
Address 37382 0
Cardiology Department
Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria
Country 37382 0
Australia
Phone 37382 0
+61 3 9895 4833
Fax 37382 0
+61 3 9895 4834
Email 37382 0
[email protected]
Contact person for public queries
Name 37383 0
Louise Roberts
Address 37383 0
Eastern Health
5 Arnold Street, Box Hill 3128
Victoria
Country 37383 0
Australia
Phone 37383 0
+61 3 9095 2441
Fax 37383 0
+61 3 9899 6810
Email 37383 0
[email protected]
Contact person for scientific queries
Name 37384 0
Gishel New
Address 37384 0
Cardiology Department
Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria
Country 37384 0
Australia
Phone 37384 0
+61 3 9895 4833
Fax 37384 0
+61 3 9895 4834
Email 37384 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.