PICSO in NSTEMI

ISRCTN	ISRCTN25579748
DOI	https://doi.org/10.1186/ISRCTN25579748
Secondary identifying numbers	18107

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary under review

Mrs Nicola Bowers
Scientific

Wycombe General Hospital
Queen Alexandra Road
High Wycombe
Buckinghamshire
HP11 2TT
United Kingdom

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	PICSO in NSTEMI registry: Pressure controlled intermittent coronary sinus occlusion in NonST elevation Myocardial Infarction
Study objectives	Aim of this study is to evaluate whether pressure controlled intermittent coronary sinus occlusion (PICSO) reduces the level of microvascular obstruction (MVO) in patients with acute NSTEMI, thereby reducing infarct size.
Ethics approval(s)	London - Stanmore Research Ethics Committee, 04/11/2014, ref: 14/LO/1365
Health condition(s) or problem(s) studied	Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	Pressure controlled Intermittent Coronary Sinus Occlusion (PICSO)
Intervention type	Procedure/Surgery
Primary outcome measure	Infarct Size reduction; Timepoint(s): Infarct Size reduction from days 35 after PCI to 4 months post PCI
Secondary outcome measures	Not provided at time of registration
Overall study start date	05/01/2015
Completion date	05/02/2016

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Key inclusion criteria	1. Ischemic symptoms such as angina pectoris for more than 20 minutes 2. Occurrence of previous symptoms less than 72 hours before enrolment 3. Cardiac troponin levels above the 99th percentile at presentation and 4. Age range: 18-75
Key exclusion criteria	1. Cardiogenic shock 2. STEMI 3. Coronary anatomy ineligible for Coronary Sinus cannulation. 4. Indication for acute bypass surgery 5. Pregnancy 6. Current participation in another study 7. Comorbidity with a life expectancy of less than 6 months 8. Contraindication to cMRI
Date of first enrolment	05/01/2015
Date of final enrolment	05/02/2016

Wycombe General Hospital

Queen Alexandra Road
High Wycombe
Buckinghamshire
HP11 2TT
United Kingdom

Buckinghamshire Healthcare NHS Trust
Hospital/treatment centre

Department of R&D
Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP21 8AL
England
United Kingdom

"ROR"	https://ror.org/037f2xv36

Industry

Miracor Medical Systems GmbH (Austria)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

16/03/2018: No publications found, verifying study status with principal investigator.