Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Ex… (NCT05644925) | Clinical Trial Compass
WithdrawnNot Applicable
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
Stopped: Lack of financial support for recruitment and follow-up activities.
0Started 2022-11-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years old.
✓. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
✓. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
✓. Pre-PCI TIMI flow 0-1.
✓. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
✓. The patient is eligible for primary PCI.
✓. Informed consent received and signed for study enrollment.
Exclusion criteria
✕. Contraindication to coronary angiogram or PCI.
✕. Implants or foreign bodies in the coronary sinus.
✕. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
What they're measuring
1
Superiority of PiCSO in reducing microvascular dysfunction
Timeframe: After primary PCI at time 0 after intervention