NCT02388139

Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (REN-ACS)

Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (AMI) Included in the Romanian National Programme of Primary Percutaneous Revascularisation - a Single Center Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aims * assessment of renal artery stenosis incidence in consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation; * generating a cardio-renal-metabolic profile in patients with renal atherosclerotic disease; * creating a local registry (based on European CARDS percutaneous interventional registries) which also includes renal, metabolic and vascular data; * reporting long-term follow-up data on major cardiac adverse events (MACE) in the study group.

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 and specific non-genetic biomarkers; * 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); * metabolic data (obtained from body composition monitoring) - body water, body fat tissue; * renal arteries angiographic details (two independent operators evaluate stenosis based on a predefined scale); * renal dimensions; * measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial); * heart rate variability; * in-hospital and one month follow-up MACE;

Conditions

• Hypertension, Renovascular
• Renal Artery Stenosis
• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	renal artery angiography	preprocedural renal arteriogram 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 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. An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
PROCEDURE	coronarography
PROCEDURE	coronary angioplasty
PROCEDURE	pulse wave velocity measurement	is a measure of arterial stiffness with Sphigmocore device.
PROCEDURE	body composition monitoring	using Fresenius device

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-10-01
• Completion: 2017-06-01
• First posted: 2015-03-13
• Last updated: 2016-01-13

Locations

1 site across 1 country: Romania