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Completed

NCT Number: NCT01244841

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fast post MI care

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison between the study groups of readmission rates within 1 month.

    Time frame: 30 days

  2. Comparison between the study groups of compliance with, and target dosing of medical therapy.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

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

Acronym: INUT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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