Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI) (INUT)
|ClinicalTrials.gov Identifier: NCT01244841|
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : May 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Procedure: fast post MI care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect on 30 Day Health Status After Early Discharge in Patient With ST Elevation Myocardial Infarction Treated With Primary PCI|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients. [ Time Frame: 1 month ]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.
- Comparison between the study groups of readmission rates within 1 month. [ Time Frame: 30 days ]
- Comparison between the study groups of compliance with, and target dosing of medical therapy. [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244841
|Stavanger University Hospital|
|Stavanger, Rogaland, Norway, 4068|
|Principal Investigator:||Tor Melberg, MD PhD||Stavanger University Hospital, Norway|