Long-term outcomes for heart attack patients treated with a naturally-dissolving blood vessel support

ISRCTN	ISRCTN43696201
DOI	https://doi.org/10.1186/ISRCTN43696201

Submission date: 04/06/2019
Registration date: 07/06/2019
Last edited: 20/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
A bioresorbable scaffold (BRS) can hypothetically decrease the risk of an adverse cardiac event in the long-term perspective. The BRS is a device which is inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, manufactured from a material that may dissolve or be absorbed in the body. The of the study is to assess the long-term outcomes of using a BRS for the urgent treatment of coronary artery block.

Who can participate?
Patients undergoing surgery for STEMI type heart attack.

What does the study involve?
Patients undergoing urgent surgery for a STEMI type heart attack will be treated using the BRS and followed up over 5-years during their regular appointments.

What are the possible benefits and risks of participating?
An improved long-term outcome with normal vessel anatomy (no vessel metallic cage as the device is resorbed over time).
Higher risk of scaffold late thrombosis.

Where is the study run from?
1. University Hospital Kralovske Vinohrady third medical faculty, Charles University, Czechia
2. Military hospital Prague, Czechia

When is the study starting and how long is it expected to run for?
December 2012 to December 2020

Who is funding the study?
Univerzita Karlova v Praze (Charles University, Prague), Czechia

Who is the main contact?
Dr Petr Tousek,
petr.tousek@fnkv.cz

Contact information

Dr Petr Tousek
Scientific

University Hospital Vinohrady
Srobarova 50
Prague
10034
Czech Republic

ORCID ID	0000-0002-2598-3635
Phone	0042 067162701
Email	petr.tousek@fnkv.cz

Study information

Study design	Prospective two-centre open-label registry study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Bioresorbable scaffold implantation in STEMI patients
Study acronym	PRAGUE-19
Study hypothesis	Good longterm clinical outcome after bioresorbable scaffold (BRS) implantation, complete scaffold resorbtion at 5 year with stable lumen patency
Ethics approval(s)	1. Approved 09/01/2013, Local and multicenter ethical committee of the University Hospital Kralovske Vinohrady (Srobatrova 50, Prague 10, eticka.komise@fnkv.cz, +420267162272), ref: EK-VP/02/2013 2. Amendment approved 03/10/2018, ref: EK-VP/02/4/2013
Condition	Acute myocardial infarction with ST segment elevation
Intervention	Use of bioresorbable scaffold (AbsorbTM BRS) during primary coronary intervention. Patients enrolled in this study were treated during primary percutaneous coronary intervention (PCI) with the bioresorbable scaffold implantation (in some of the patients, optical coherence tomography (OCT) was performed just after BRS was implanted - if clinically possible). Patients are followed by clinical and phone controls during 5 years. First 25 eligible patients that agreed with the contol invasive imaging underwent 5 year coronary angiography and OCT.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)
Primary outcome measure	At 5 years: 1. Death using patient records 2. MI using patient records 3. Target vessel revascularization as recorded in records by a specialist
Secondary outcome measures	Vessel invasive assessment using QCA and optical coherence tomography at baseline and 5 years.
Overall study start date	01/12/2012
Overall study end date	15/12/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	130
Total final enrolment	117
Participant inclusion criteria	1. STEMI patients 2. Sign informed consent
Participant exclusion criteria	1. Severe calcification 2. Do not meet specified vessel size 3. Length of the lesion more than 28mm 4. Indication for anticoagulation, cardiogenic shock
Recruitment start date	15/12/2012
Recruitment end date	15/12/2015

Locations

Countries of recruitment

Czech Republic

Study participating centres

University Hospital Kralovske Vinohrady third medical faculty, Charles university

Srobarova 50
Prague
10034
Czech Republic

Military hospital Prague

U Vojenské nemocnice 1200
Prague
16902
Czech Republic

Sponsor information

Charles University, University Research programme UNCE 02 and PROGRES Q38
University/education

Ruska 87
Prague
10000
Czech Republic

Phone	267162701
Email	petr.tousek@f3.cuni.cz
Website	www.cuni.cz
"ROR"	https://ror.org/024d6js02

Funders

Funder type

University/education

Univerzita Karlova v Praze
Government organisation / Universities (academic only)

Alternative name(s): Charles University, Charles University in Prague, Univerzita Karlova, Karls-Universität zu Prag, UK
Location: Czech Republic

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Pilot study published in 2014, 2-year interim analysis published in 2016, imaging analysis planned to published in 2019, final results in 2020.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical restrictions on data sharing.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	interim analysis	17/05/2016	05/06/2019	Yes	No
Other publications	pilot study	01/03/2014	05/06/2019	Yes	No
Results article		30/01/2020	03/02/2020	Yes	No

Editorial Notes

20/01/2022: Internal review.
03/02/2020: Publication reference added.
07/06/2019: Trial’s existence confirmed by University Hospital Kralovske Vinohrady.