Last reviewed · How we verify
NCT05644925: PiCSO-STEMI
Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
NA trial testing PiCSO Impulse System in Anterior Myocardial Infarction. Withdrawn.
21 June 2024
Quick facts
| Lead sponsor | Fundacio Privada Mon Clinic Barcelona |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 14 November 2022 |
| Primary completion | 21 June 2024 |
| Estimated completion | 21 June 2024 |
Drugs / interventions tested
- PiCSO Impulse System
- Percutaneous Coronary Intervention (PCI)
Conditions studied
- Anterior Myocardial Infarction — all drugs for Anterior Myocardial Infarction →
Sponsor
Fundacio Privada Mon Clinic Barcelona
Who can join
18 and older, any sex, with Anterior Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05644925
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of PiCSO Impulse System
Trials testing the same drug.
- NCT05497011 — A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients · NA · withdrawn
- NCT04958421 — A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infar · NA · terminated
Other Fundacio Privada Mon Clinic Barcelona trials
Trials by the same sponsor.
- NCT07000266 — The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack · NA · active not recruiting
- NCT06607705 — Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor · NA · recruiting
- NCT06282861 — ANTES B+ Clinical Trial · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05644925 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacio Privada Mon Clinic Barcelona
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05644925.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing