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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01244841
First received: October 12, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Procedure: fast post MI care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect on 30 Day Health Status After Early Discharge in Patient With ST Elevation Myocardial Infarction Treated With Primary PCI

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Comparison between the study groups of readmission rates within 1 month. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Comparison between the study groups of compliance with, and target dosing of medical therapy. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: September 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Randomised to standard post MI care and length of hospital stay decided by treating physician.
Active Comparator: 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.
Procedure: fast post MI care
All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244841

Locations
Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Tor Melberg, MD PhD Stavanger University Hospital, Norway
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01244841     History of Changes
Other Study ID Numbers: 2009/807-4
Study First Received: October 12, 2010
Last Updated: May 7, 2013
Health Authority: Norway: Ministry of Health and Care Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
ST elevation acute myocardial infarction
Primary percutaneous coronary intervention
Discharge
Health status
Quality of care

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014