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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02655341
Acronym
HYD-AMI
Enrollment
400
Registered
2016-01-14
Start date
2016-01-31
Completion date
2018-01-31
Last updated
2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Acute Myocardial Infarction, Renal Artery Stenosis

Keywords

Dehydration, Primary PCI, Acute Myocardial Infarction, Bioimpedance, Renal Angiography

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.

Interventions

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

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.

PROCEDUREPrimary Percutaneous Coronary Intervention

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

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

Sponsors

Grigore T. Popa University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)2 yearsAssessment of hydration status through body composition monitoring BCM before and after coronary intervention

Secondary

MeasureTime frameDescription
Renal Artery Stenosis2 yearsAssessment of renal artery stenosis incidence in consecutive AMI patients;

Countries

Romania

Contacts

Primary ContactAlexandru Burlacu, M.D.
alburlacu@yahoo.com0040744488580
Backup ContactAdrian Covic, Professor
accovic@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026