NCT02655341UnknownNot 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 enrollmentStarted: January 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
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)
Investigators
Professor Adrian Covic
Professor Adrian Covic, MD, PhD
Grigore T. Popa University of Medicine and Pharmacy
Study Sites (1)
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