| Registry | NCT04034940, acronym OxiSTEMIhFABP |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 200 (Estimated) |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy (Other); collaborators: Cardiovascular Diseases Institute IASI, Romania |
| Conditions | STEMI, Oxidative Stress, Oxidative Stress Induction, Primary PCI, hFABP, Left Ventricular Dysfunction, BCM |
| Interventions | Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients (Other) |
| Dates | start 2019-08-01 (estimated), primary completion 2020-07-01 (estimated), completion 2020-08-01 (estimated), first posted 2019-07-29, last updated 2019-07-30 |
| Locations | 1 site in Romania |
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The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Glutathione Peroxidase at patients with acute myocardial infarction STEMI referred for primary PCI; The investigators also aim to evaluate cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST in these patients with acute myocardial infarction referred for primary PCI; Also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (BCM - Fresenius Care) at the moment of admission.
The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.
Gathered data:
* Descriptive general demographic data;
* Previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);
* Cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
* Oxidative Stress biomarkers: Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione ;
* Cardiac necrosis markers: Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and OGT;
* Routine biological data;
* Metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
* Information regarding primary PCI (less than 12 hours of ischemic symptoms);
* Coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
* Echocardiography at admission (LVEF);
* Measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
* Calculating of cardiovascular risk scores: Syntax Score, Framingham score, ASSIGN score, QRISK2 score, PROCAM score, CRUSADE score, GRACE score, CHADS VASc score, MESA score, ASCVD score, Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety;
* In-hospital and one month follow-up MACE.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| primary PCI STEMI patients | Other | Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients | All Patients with AMI refered for primary PCI in single center |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Adults with ST elevation Myocardial Infarction (<12h) diagnostic confirmed; * Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI); Exclusion Criteria: * Patients who do not sign informed consent for primary PCI
| Facility | City | Country | Status |
|---|---|---|---|
| Cardiovascular Diseases Institute Iasi | Iași, Iaşi | Romania | Recruiting |