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

• Conditions: Renal Artery Stenosis; Myocardial Infarction; Hypertension, Renovascular

• Registration Number: NCT02388139
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

Brief 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;

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-13
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13
• Primary Completion: 2016-10
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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);

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
renal artery stenosis incidence	2 years	assessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;

Secondary Outcome Measures

Name	Time	Method
cardio-renal-metabolic profile in patients with renal atherosclerotic disease;	2 years

Trial Locations

Locations (1)

Cardiology Departament "IBCV" Hospital; 🇷🇴 Iasi, Romania