Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI) (INUT)
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|ClinicalTrials.gov Identifier: NCT01244841|
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : May 9, 2013
|Condition or disease||Intervention/treatment|
|Acute Myocardial Infarction||Procedure: fast post MI care|
|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|
|Primary Completion Date :||November 2012|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|