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Safe and effective early discharge of patients with low-risk coronary artery disease

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?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000200785
Acronym
SEED
Enrollment
300
Registered
2013-02-19
Start date
2013-03-01
Completion date
2014-02-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Traditionally patients presenting to hospital with a heart attack are hospitalized for at least 5-7 days to monitor for complications such as increasing shortness of breath, recurrence of chest pain and fast irregular heart rate and also to increase their medications and receive a basic understanding of future management of their chest pain. A randomized trial in Canada showed that early discharge from hospital for low risk heart attack patients was feasible and safe when combined with close nursing follow up at home. We propose to randomize low risk heart attack patients to early discharge (<72 hours) with hospital-in-the-home (HITH) nurses and doctors compared with conventional 4-5 day stay in hospital. The aims of this study are 1. To prove that an early discharge strategy is safe and acceptable to patients with no increase in deaths, adverse events or unexpected readmission to hospital 2. To evaluate the patients’ experience and quality of life in both groups using questionnaires. 3. To examine the cost effectiveness of early discharge from hospital to HITH versus conventional 4-5 day hospital stay. Patients presenting to Box Hill Hospital with a heart attack and have undergone coronary angiogram and are treated with either medical therapy such as medications or angioplasty and stent will be screened using validated tools to assess for low risk. They will then be randomized to either early discharge with HITH (intervention group) or conventional 4-5 day hospital stay (control group). About 300 hundred patients will be recruited for the trial. The intervention group will be discharged from hospital before 72 hours and followed up daily by HITH nurse for at least 3 days. In the first week they will be reviewed by the HITH consultant doctor at the Maroondah clinic. The control group will be discharged home according to standard care at day 4 or 5. The main outcomes to be measured are: all-cause death, readmission or re-presentation to hospital due to chest pain, recurrent heart attacks or heart failure, as well as procedural and non-cardiac complications related to the index event at 30 days. The information will be gathered via phone interviews and medical records. Health-related quality of life and patients’ experiences of in-patient care will be evaluated using validated questionnaires. A telephone call to all patients at 6 weeks and 3 months will remind them about completing the questionnaires, and include a brief interview regarding re-presentation to the hospital, readmission, compliance with medications, attendance at cardiac rehabilitation and smoking cessation. All information collected will remain confidential and be de-identified for research purposes. The cost-effectiveness (reduced length of stay) of the early discharge strategy will also be analysed.

Interventions

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.

Sponsors

Cardiology Department Eastern Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants who suffer from heart attacks, over 18 years of age and are willing and able to sign informed consent forms

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026