Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction
NCT ID: NCT02655341
Last Updated: 2016-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2016-01-31
2018-01-31
Brief Summary
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* 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.
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Consecutive STEMI Patients
All patients with AMI referred for primary PCI in a single centre
Body Composition Monitoring
using Fresenius device; two measurements before and after coronary intervention;
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.
Primary Percutaneous Coronary Intervention
An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
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
Interventions
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Body Composition Monitoring
using Fresenius device; two measurements before and after coronary intervention;
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.
Primary Percutaneous Coronary Intervention
An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Grigore T. Popa University of Medicine and Pharmacy
OTHER
Responsible Party
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Professor Adrian Covic
Professor Adrian Covic, MD, PhD
Principal Investigators
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Adrian Covic, Professor
Role: PRINCIPAL_INVESTIGATOR
Grigore T. Popa University of Medicine and Pharmacy
Locations
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Cardiovascular Diseases Institute - IASI
Iași, Iaşi, Romania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYD-AMI001
Identifier Type: -
Identifier Source: org_study_id
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