HYD-AMI: Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction

Sponsor

Grigore T. Popa University of Medicine and Pharmacy (Other)

Overall Status

Unknown status

CT.gov ID

NCT02655341

Collaborator

(none)

400

Enrollment

Location

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dehydration Acute Myocardial Infarction Renal Artery Stenosis	Device: Body Composition Monitoring Procedure: Coronarography Procedure: Primary Percutaneous Coronary Intervention Procedure: Renal Angiography

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Consecutive STEMI Patients All patients with AMI referred for primary PCI in a single centre	Device: Body Composition Monitoring using Fresenius device; two measurements before and after coronary intervention; Other Names: BCM 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. Other Names: Coronary Artery Angiography Procedure: Primary Percutaneous Coronary Intervention An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty. Other Names: Primary PCI 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 Other Names: RA

Arm

Intervention/Treatment

Consecutive STEMI Patients

All patients with AMI referred for primary PCI in a single centre

Device: Body Composition Monitoring

using Fresenius device; two measurements before and after coronary intervention;

Other Names:

BCM

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.

Other Names:

Coronary Artery Angiography

Procedure: Primary Percutaneous Coronary Intervention

An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.

Other Names:

Primary PCI

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

Other Names:

Outcome Measures

Primary Outcome Measures

Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI) [2 years]
Assessment of hydration status through body composition monitoring BCM before and after coronary intervention

Secondary Outcome Measures

Renal Artery Stenosis [2 years]
Assessment of renal artery stenosis incidence in consecutive AMI patients;

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);