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

Acute Myocardial Infarction Clinical Trial

— HYD-AMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02655341
• Other study ID #: HYD-AMI001
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2016
• Last updated: January 12, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Alexandru Burlacu, M.D.
• Phone: 0040744488580
• Email: alburlacu[@]yahoo.com
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Dehydration
• Infarction
• Myocardial Infarction
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

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.
• 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

Locations

Country	Name	City	State
Romania	Cardiovascular Diseases Institute - IASI	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Renal Artery Stenosis	Assessment of renal artery stenosis incidence in consecutive AMI patients;	2 years	No