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

Acute Myocardial Infarction Clinical Trial

— INUT  

Official title:

The Effect on 30 Day Health Status After Early Discharge in Patient With ST Elevation Myocardial Infarction Treated With Primary PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244841
• Other study ID #: 2009/807-4
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: May 7, 2013
• Start date: September 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ministry of Health and Care ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• fast post MI care
All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients.	This is an equivalence study comparing health related quality of life(HRQOL) and quality-of-care satisfaction between the 3 days stay and standard regimen groups at 30 days after AMI. The scores of the SF-36, Seattle Angina Questionaire and Hospital Anxiety & Depression Scale for patients in both study groups will be compared. The forms will be filled out by the patients at baseline and at 30 days follow-up.	1 month	No
Secondary	Comparison between the study groups of readmission rates within 1 month.		30 days	No
Secondary	Comparison between the study groups of compliance with, and target dosing of medical therapy.		1 month	No