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

NCT01244841 | Completed

• 1 other identifier: 2009/807-4
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

ST elevation acute myocardial infarction; Primary percutaneous coronary intervention; Discharge; Health status; Quality of care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

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

  30 days

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

  1 month

Study Arms (2)

Standard care

NO INTERVENTION

Randomised to standard post MI care and length of hospital stay decided by treating physician.

Early discharge

ACTIVE COMPARATOR

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

Interventions

fast post MI care PROCEDURE

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

Early discharge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ST elevation acute myocardial infarction
• Undergoing primary PCI

You may not qualify if:

• 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.
• Early discharge impossible due to social, nursing or family reasons.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Location

Study Officials

• Tor Melberg, MD PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: November 19, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

NO (1)