Condition category
Circulatory System
Date applied
04/02/2015
Date assigned
04/02/2015
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nicola Bowers

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18107

Study information

Scientific title

PICSO in NSTEMI registry. Pressure controlled intermittent coronary sinus occlusion in NonST elevation Myocardial Infarction.

Acronym

Study hypothesis

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

14/LO/1365

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Pressure controlled Intermittent Coronary Sinus Occlusion (PICSO)

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Infarct Size reduction; Timepoint(s): Infarct Size reduction from days 35
after PCI to 4 months post PCI

Secondary outcome measures

N/A

Overall trial start date

05/01/2015

Overall trial end date

05/02/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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

Recruitment start date

05/01/2015

Recruitment end date

05/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Buckinghamshire Healthcare NHS Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Miracor Medical Systems GmbH (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes