Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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Aims: evaluate the hydric status through bioimpedance spectroscopy in consecutive acute myocardial infarction patients referred for primary PCI; assessment of renal artery stenosis incidence through renal angiography in consecutive STEMI patients; fully characterize the complex hydration, metabolic and endothelial profile of these patients in the attempt to define the role played by dehydration in the complex dynamics of acute myocardial infarction.

Detailed Description
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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); 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); renal arteries angiographic details performed in the same time with PCI (two independent operators evaluate stenosis based on a predefined scale); renal diameters; measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial); in-hospital and one month follow-up MACE.

Official Title
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Hydration Status Assessment Through Body Composition Monitoring And Renal Artery Stenosis Evaluation in Patients With Acute Myocardial Infarction Referred For Primary PCI

Conditions
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Dehydration, Acute Myocardial Infarction, Renal Artery Stenosis

Intervention / Treatment
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* Device: Body Composition Monitoring
* Procedure: Coronarography
* Procedure: Primary Percutaneous Coronary Intervention
* Procedure: Renal Angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consecutive STEMI Patients<br>All patients with AMI referred for primary PCI in a single centre | Device: Body Composition Monitoring<br>* using Fresenius device; two measurements before and after coronary intervention;<br>* Other names: BCM;Procedure: Coronarography<br>* Preprocedural coronary arteriography is obtained after sterile preparation and draping of the patient, conscious sedation, infiltration of local anesthetic (lidocaine solution) at the femoral access site, placement of an arterial sheath in the femoral artery, and advancement of the renal guide catheter over a 0.035-in guidewire under fluoroscopic guidance. After the tip of the guide catheter is positioned at the ostium of the left coronary stem, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording.<br>* Other names: Coronary Artery Angiography;Procedure: Primary Percutaneous Coronary Intervention<br>* An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.<br>* Other names: Primary PCI;Procedure: Renal Angiography<br>* After the tip of the guide catheter is positioned at the ostium of the renal artery, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording. This procedure is performed in the same time with primary PCI<br>* Other names: RA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI) | Assessment of hydration status through body composition monitoring BCM before and after coronary intervention | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Artery Stenosis | Assessment of renal artery stenosis incidence in consecutive AMI patients; | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dehydration, Primary PCI, Acute Myocardial Infarction, Bioimpedance, Renal Angiography