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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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

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Hypertension, Renovascular Renal Artery Stenosis Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

coronarography

Intervention Type PROCEDURE

coronary angioplasty

Intervention Type PROCEDURE

pulse wave velocity measurement

is a measure of arterial stiffness with Sphigmocore device.

Intervention Type PROCEDURE

body composition monitoring

using Fresenius device

Intervention Type PROCEDURE

Other Intervention Names

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pPCI PWV BCM

Eligibility Criteria

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Inclusion Criteria

* adults with AMI (\<12h) diagnostic confirmed;
* included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);