Condition category
Circulatory System
Date applied
26/11/2014
Date assigned
04/12/2014
Last edited
04/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
According to the present guidelines, low risk patients who undergo primary
percutaneous coronary intervention (PPCI) for acute myocardial infarction (AMI), could be discharged safely 3 days after admission. In this study, we investigated the safety and feasibility of next-day hospital discharge in patients treated with PPCI.

Who can participate?
Low risk PPCI patients.

What does the study involve?
Patients discharged within 36 hours after admission.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Isala Hospital, Zwolle, Netherlands

When is the study starting and how long is it expected to run for?
July 2008 to July 2013

Who is funding the study?
Isala Hospital, Zwolle, Netherlands

Who is the main contact?
Arnoud van’t Hof
Ahmet Adiyaman

Trial website

Contact information

Type

Scientific

Primary contact

MD, PhD, FESC Arnoud van 't Hof

ORCID ID

Contact details

Departement of Cardiology
Isala Hospital
Zwolle
8025 AB
Netherlands
+3138 4242374
v.r.c.derks@isala.nl

Type

Scientific

Additional contact

MD, PhD Ahmet Adiyaman

ORCID ID

Contact details

Departement of Cardiology
Isala Hospital
Zwolle
8025 AB
Netherlands
+31 384248012
a.adiyaman@isala.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Diagr. 9196

Study information

Scientific title

Safety and Feasibility of Next-Day Discharge after Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction

Acronym

Short Stay

Study hypothesis

Very early discharge (e.g. within one day) in ST segment elevation myocardial infarction (STEMI) patients undergoing uncomplicated primary PCI, and with low risk based on a validated risk score, is safe and feasible

Ethics approval

Under the Dutch Law for medical scientific research in humans (Wet Medisch-wetenschappelijk Onderzoek met mensen WMO)no ethics approval was needed. There was no submission to an ethics committee.

Study design

Prospective single centre safety and feasibility study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction

Intervention

Patients were discharged within 36 hours after admission and controlled by specialized nurses in the outpatient clinic at the third and fourth day after PPCI.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Occurrence of major adverse cardiac event, defined as death, re-myocardial infarction, urgent target vessel revascularisation and myocardial infarction related (potentially)
2. Life threatening arrhythmias, as defined as ventricular tachycardia and complete atrioventricular block

Secondary outcome measures

1. Re-admission rates
2. Number of visits to emergency ward of any cause at 30 day follow-up and 1 year follow-up

Overall trial start date

01/07/2008

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with ST-elevated myocardial infarction, successfully treated with PPCI
2. Procedural was defined as an uncomplicated procedure resulting in restoration of flow with a sufficient myocardial blush in the area of the infarction related vessel
3. Procedure was performed via the femoral artery (Seldinger technique)
4. Patient with a Zwolle risk Score ≤ 3
5. Patient that is, after discharge, able to reach the hospital within 30 minutes
6. Patient that gives written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Patients with untreated significant coronary artery stenosis
2. Patients <18 years old, or unable to co-operate with the study
3. Patients living >30 km from the PCI center

Recruitment start date

01/07/2008

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Isala
Dr. v. Heesweg 2
Zwolle
8025 AB
Netherlands

Sponsor information

Organisation

Maatschap Cardiologie, Isala Hospital

Sponsor details

Dr. v. Heesweg 2
Zwolle
8025 AB
Netherlands
+31 38 424 4295
v.r.c.derks@isala.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Maatschap cardiologie Isala Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planning to submit a report of the results for the first 250 patients in the upcoming 2 months. The results will consist of the detailed survival and adverse events in the first 30 days following inclusion, and mortality data of the first year after inclusion.

Intention to publish date

31/03/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes