Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI)

NCT ID: NCT01244841

Last Updated: 2013-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-11-30

Brief Summary

In patients with ST elevation myocardial infarction (STEMI)treated with primary percutaneous coronary intervention (PPCI) a subset with low risk for late complications can be identified. Early discharge (<72h) of these patients can compromise initiation of prophylaxis, information and other investigations. The researchers want to investigate prospectively whether early discharge compared to regular care have comparable patient centered outcomes at 30 days follow-up.

Detailed Description

The safety and feasibility of early discharge of low-risk STEMI treated with thrombolysis or PPCI patients have previously been investigated. It is possible to identify a subset of patients with very low risk for subsequent cardiac events in the short-term, where prolonged hospital stay beyond three days does not alter the outcome. Early discharge have however, not been included in STEMI management guidelines formally. The effects of this discharge regimen on STEMI patients' health status (symptoms, functional capacity and quality of life) is not previously investigated. Shorter hospital stays saves health care resources. On the other hand, short in-hospital stay can affect the perceived satisfaction of care. Initiation of medical treatment, patient education, life style counselling and follow-up routines may suffer. Additionally, early discharge can increase anxiety and symptom level reducing the health related quality of life (HRQOL) and also lead to readmission. Patient satisfaction has become a recognised measure of the quality of health care.Currently there is little information on how early discharge influence the patients' satisfaction with the health care or the subjective perceived of HRQOL after discharge. We therefore wish to perform a prospective trial comparing outcomes with regard to satisfaction of care and HRQOL in patients admitted for STEMI randomised to either early discharge or standard care.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

Randomised to standard post MI care and length of hospital stay decided by treating physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Early discharge

Randomised patient where all post MI investigations, treatment, follow-up plans and information will be performed within 3 days, and the patients are thereafter discharged.

Group Type: ACTIVE_COMPARATOR

fast post MI care

Intervention Type: PROCEDURE

All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.

Interventions

fast post MI care

All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ST elevation acute myocardial infarction
• Undergoing primary PCI

Exclusion Criteria

• Zwolle low risk criteria score >4
• Re-infarction, post AMI ischemia.
• Need for urgent repeat invasive procedures.
• Non-cardiac complication (bleeding, stroke oa.) or concomitant diseases likely to increase length of hospital stay.
• Patient or caring physician refuse to early discharge or study inclusion.
• Early discharge impossible due to social, nursing or family reasons.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tor Melberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger University Hospital

Stavanger, Rogaland, Norway

Countries

Norway

Other Identifiers

2009/807-4

Identifier Type: -

Identifier Source: org_study_id