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

G

Grigore T. Popa University of Medicine and Pharmacy

Status

Unknown

Conditions

Dehydration
Renal Artery Stenosis
Acute Myocardial Infarction

Treatments

Procedure: Primary Percutaneous Coronary Intervention
Procedure: Coronarography
Device: Body Composition Monitoring
Procedure: Renal Angiography

Study type

Observational

Funder types

Other

Identifiers

NCT02655341
HYD-AMI001

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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);

Exclusion criteria

  • patients who do not sign informed consent for primary PCI

Trial design

400 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Alexandru Burlacu, M.D.; Adrian Covic, Professor

Data sourced from clinicaltrials.gov

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