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

• Conditions: Dehydration; Acute Myocardial Infarction; Renal Artery Stenosis
• Interventions: Device: Body Composition Monitoring; Procedure: Coronarography; Procedure: Primary Percutaneous Coronary Intervention; Procedure: Renal Angiography

• Registration Number: NCT02655341
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

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.

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-12
• Last Update Submitted: 2016-01-12
• Study First Posted: 2016-01-14
• Last Update Posted: 2016-01-14
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive STEMI Patients	Primary Percutaneous Coronary Intervention	All patients with AMI referred for primary PCI in a single centre
Consecutive STEMI Patients	Coronarography	All patients with AMI referred for primary PCI in a single centre
Consecutive STEMI Patients	Body Composition Monitoring	All patients with AMI referred for primary PCI in a single centre
Consecutive STEMI Patients	Renal Angiography	All patients with AMI referred for primary PCI in a single centre

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Renal Artery Stenosis	2 years	Assessment of renal artery stenosis incidence in consecutive AMI patients;

Trial Locations

Locations (1)

Cardiovascular Diseases Institute - IASI; 🇷🇴 Iasi, Romania