PICSO in NSTEMI
| ISRCTN | ISRCTN25579748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25579748 |
| Protocol serial number | 18107 |
| Sponsor | Buckinghamshire Healthcare NHS Trust |
| Funder | Miracor Medical Systems GmbH (Austria) |
- Submission date
- 04/02/2015
- Registration date
- 04/02/2015
- Last edited
- 16/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Mrs Nicola Bowers
Scientific
Scientific
Wycombe General Hospital
Queen Alexandra Road
High Wycombe
Buckinghamshire
HP11 2TT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Infarct Size reduction; Timepoint(s): Infarct Size reduction from days 35 after PCI to 4 months post PCI |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 05/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wycombe General Hospital
Queen Alexandra Road
High Wycombe
Buckinghamshire
HP11 2TT
United Kingdom
High Wycombe
Buckinghamshire
HP11 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/03/2018: No publications found, verifying study status with principal investigator.
