Skip to content

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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02388139
Acronym
REN-ACS
Enrollment
200
Registered
2015-03-13
Start date
2014-10-31
Completion date
2017-06-30
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renovascular, Renal Artery Stenosis, Myocardial Infarction

Keywords

acute myocardial infarction, renal artery stenosis

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;

Interventions

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.

PROCEDUREcoronary angioplasty

is a measure of arterial stiffness with Sphigmocore device.

using Fresenius device

Sponsors

Grigore T. Popa University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
renal artery stenosis incidence2 yearsassessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;

Secondary

MeasureTime frame
cardio-renal-metabolic profile in patients with renal atherosclerotic disease;2 years

Countries

Romania

Contacts

Primary ContactAlexandru Burlacu, MD
alburlacu@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026