Viewing Study NCT02388139



Ignite Creation Date: 2024-05-06 @ 3:49 AM
Last Modification Date: 2024-10-26 @ 11:39 AM
Study NCT ID: NCT02388139
Status: UNKNOWN
Last Update Posted: 2016-01-13
First Post: 2015-03-09

Brief Title: Cardiovascular Renal and Metabolic Profile in Patients With Acute Myocardial Infarction REN-ACS
Sponsor: Grigore T Popa University of Medicine and Pharmacy
Organization: Grigore T Popa University of Medicine and Pharmacy

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2016-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REN-ACS
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None