Cardiovascular, Renal & Metabolic Profile in Patients With Acute

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02388139
Study type	Observational
Source	Grigore T. Popa University of Medicine and Pharmacy
Contact	Alexandru Burlacu, MD
Email	alburlacu@yahoo.com
Status	Recruiting
Phase	N/A
Start date	October 2014
Completion date	June 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms