Clinical trial NCT02655341: Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction
Official title: Hydration Status Assessment Through Body Composition Monitoring And Renal Artery Stenosis Evaluation in Patients With Acute Myocardial Infarction Referred For Primary PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dehydration
Acute Myocardial Infarction
Renal Artery Stenosis
Keywords: Dehydration
Primary PCI
Acute Myocardial Infarction
Bioimpedance
Renal Angiography
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria: study population consists of consecutive patients admitted with acute myocardial infarction (\<12h) diagnostic confirmed;

* included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
* have read and signed standard informed consent for angiography in AMI;

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.

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

Primary outcomes:
measure: Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)
timeFrame: 2 years
Secondary outcomes:
measure: Renal Artery Stenosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Cardiovascular Diseases Institute - IASI
Study officials:
affiliation: Grigore T. Popa University of Medicine and Pharmacy
name: Adrian Covic, Professor
role: PRINCIPAL_INVESTIGATOR
References: