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

NCT02388139 | Unknown

• 1 other identifier: REN-ACS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Renovascular; Renal Artery Stenosis; Myocardial Infarction

Keywords

acute myocardial infarction; renal artery stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• cardio-renal-metabolic profile in patients with renal atherosclerotic disease;

  2 years

Interventions

renal artery angiography PROCEDURE

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 PROCEDURE

coronary angioplasty PROCEDURE

Also known as: pPCI

pulse wave velocity measurement PROCEDURE

is a measure of arterial stiffness with Sphigmocore device.

Also known as: PWV

body composition monitoring PROCEDURE

using Fresenius device

Also known as: BCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* inclusion criteria: study population consists of all consecutive patients admitted with AMI (\<12h) diagnostic confirmed; * included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI); * have read and signed standard informed consent for angiography in AMI;

You may qualify if:

• adults with AMI (\<12h) diagnostic confirmed;
• included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

You may not qualify if:

• none

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Cardiology Departament "IBCV" Hospital

Iași, 700503, Romania

RECRUITING

Related Publications (1)

• Burlacu A, Siriopol D, Voroneanu L, Nistor I, Hogas S, Nicolae A, Nedelciuc I, Tinica G, Covic A. Atherosclerotic Renal Artery Stenosis Prevalence and Correlations in Acute Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Interventions: Data From Nonrandomized Single-Center Study (REN-ACS)-A Single Center, Prospective, Observational Study. J Am Heart Assoc. 2015 Oct 12;4(10):e002379. doi: 10.1161/JAHA.115.002379.

  PMID: 26459932 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum creatinine, serum urea, lipid profile, glycemia, haemoglobin, etc

MeSH Terms

Conditions

Hypertension, Renovascular; Renal Artery Obstruction; Myocardial Infarction

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Hypertension, Renal; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Alexandru Burlacu, MD

  University of Medicine and Pharmacy "Gr T Popa" Iasi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandru Burlacu, MD

CONTACT

alburlacu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor coordinator

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

RO (1)