Next-day discharge after primary percutaneous Coronary Intervention PCI
| ISRCTN | ISRCTN15017070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15017070 |
| Secondary identifying numbers | Diagr. 9196 |
- Submission date
- 26/11/2014
- Registration date
- 04/12/2014
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Departement of Cardiology
Isala Hospital
Zwolle
8025 AB
Netherlands
| Phone | +3138 4242374 |
|---|---|
| v.r.c.derks@isala.nl |
Scientific
Departement of Cardiology
Isala Hospital
Zwolle
8025 AB
Netherlands
| Phone | +31 384248012 |
|---|---|
| a.adiyaman@isala.nl |
Study information
| Study design | Prospective single centre safety and feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Safety and Feasibility of Next-Day Discharge after Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction |
| Study acronym | Short Stay |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2008 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zwolle
8025 AB
Netherlands
Sponsor information
Hospital/treatment centre
Dr. v. Heesweg 2
Zwolle
8025 AB
Netherlands
| Phone | +31 38 424 4295 |
|---|---|
| v.r.c.derks@isala.nl | |
"ROR" |
https://ror.org/046a2wj10 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/03/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. 2017 results in Chapter 3 of thesis https://cris.maastrichtuniversity.nl/ws/files/12653600/c5627.pdf |
| IPD sharing plan |
Editorial Notes
05/03/2019: Thesis added to publication and dissemination plan.
