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

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02388139
• Other study ID #: REN-ACS
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: January 12, 2016
• Start date: October 2014
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Alexandru Burlacu, MD
• Email: alburlacu[@]yahoo.com
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Observational

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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Renovascular
• Infarction
• Myocardial Infarction
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Procedure:
• renal artery angiography
preprocedural renal arteriogram is obtained after sterile preparation and draping of the patient, conscious sedation, infiltration of local anesthetic (lidocaine solution) at the femoral access site, placement of an arterial sheath in the femoral artery, and advancement of the renal guide catheter over a 0.035-in guidewire under fluoroscopic guidance. After the tip of the guide catheter is positioned at the ostium of the renal artery, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording. An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
• coronarography

• coronary angioplasty

• pulse wave velocity measurement
is a measure of arterial stiffness with Sphigmocore device.
• body composition monitoring
using Fresenius device

Locations

Country	Name	City	State
Romania	Cardiology Departament "IBCV" Hospital	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal artery stenosis incidence	assessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;	2 years	Yes
Secondary	cardio-renal-metabolic profile in patients with renal atherosclerotic disease;		2 years	No