Clinical trial NCT02388139: Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (REN-ACS)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Renovascular
Renal Artery Stenosis
Myocardial Infarction
Keywords: acute myocardial infarction
renal artery stenosis
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 200
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 all consecutive patients admitted with AMI (\<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

* 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;

Eligibility criteria: 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

Primary outcomes:
measure: renal artery stenosis incidence
timeFrame: 2 years
Secondary outcomes:
measure: cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
timeFrame: 2 years
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Cardiology Departament "IBCV" Hospital
Study officials:
affiliation: University of Medicine and Pharmacy "Gr T Popa" Iasi
name: Alexandru Burlacu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burlacu A, Siriopol D, Voroneanu L, Nistor I, Hogas S, Nicolae A, Nedelciuc I, Tinica G, Covic A. Atherosclerotic Renal Artery Stenosis Prevalence and Correlations in Acute Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Interventions: Data From Nonrandomized Single-Center Study (REN-ACS)-A Single Center, Prospective, Observational Study. J Am Heart Assoc. 2015 Oct 12;4(10):e002379. doi: 10.1161/JAHA.115.002379.