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Clinical Trials/NCT02655341
NCT02655341
Unknown
Not Applicable

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

Grigore T. Popa University of Medicine and Pharmacy1 site in 1 country400 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dehydration
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Enrollment
400
Locations
1
Primary Endpoint
Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2018
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Professor Adrian Covic

Professor Adrian Covic, MD, PhD

Grigore T. Popa University of Medicine and Pharmacy

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)

Time Frame: 2 years

Assessment of hydration status through body composition monitoring BCM before and after coronary intervention

Secondary Outcomes

  • Renal Artery Stenosis(2 years)

Study Sites (1)

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