Clinical Trial: Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (REN-ACS)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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 O
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 Summary:
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;
Sponsor: Grigore T. Popa University of Medicine and Pharmacy
Current Primary Outcome: renal artery stenosis incidence [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: cardio-renal-metabolic profile in patients with renal atherosclerotic disease; [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Grigore T. Popa University of Medicine and Pharmacy
Dates:
Date Received: March 9, 2015
Date Started: October 2014
Date Completion: June 2017
Last Updated: January 12, 2016
Last Verified: January 2016