NCT02655341

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Dehydration
• Acute Myocardial Infarction
• Renal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Body Composition Monitoring	using Fresenius device; two measurements before and after coronary intervention;
PROCEDURE	Coronarography	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.
PROCEDURE	Primary Percutaneous Coronary Intervention	An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
PROCEDURE	Renal Angiography	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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2018-01-01
• First posted: 2016-01-14
• Last updated: 2016-01-14

Locations

1 site across 1 country: Romania