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

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ClinicalTrials.gov Identifier: NCT02388139
Recruitment Status : Unknown
Verified January 2016 by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy.
Recruitment status was:  Recruiting
First Posted : March 13, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

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.

Condition or disease Intervention/treatment
Hypertension, Renovascular Renal Artery Stenosis Myocardial Infarction Procedure: renal artery angiography Procedure: coronarography Procedure: coronary angioplasty Procedure: pulse wave velocity measurement Procedure: body composition monitoring

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;

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack


Intervention Details:
  • 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.
  • Procedure: coronarography
  • Procedure: coronary angioplasty
    Other Name: pPCI
  • Procedure: pulse wave velocity measurement
    is a measure of arterial stiffness with Sphigmocore device.
    Other Name: PWV
  • Procedure: body composition monitoring
    using Fresenius device
    Other Name: BCM


Primary Outcome Measures :
  1. renal artery stenosis incidence [ Time Frame: 2 years ]
    assessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;


Secondary Outcome Measures :
  1. cardio-renal-metabolic profile in patients with renal atherosclerotic disease; [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
serum creatinine, serum urea, lipid profile, glycemia, haemoglobin, etc


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388139


Contacts
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Contact: Alexandru Burlacu, MD alburlacu@yahoo.com

Locations
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Romania
Cardiology Departament "IBCV" Hospital Recruiting
Iasi, Romania, 700503
Contact: Alexandru Burlacu, MD       alburlacu@yahoo.com   
Principal Investigator: Alexandru Burlacu, MD         
Sponsors and Collaborators
Grigore T. Popa University of Medicine and Pharmacy
Investigators
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Principal Investigator: Alexandru Burlacu, MD University of Medicine and Pharmacy "Gr T Popa" Iasi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Adrian Covic, Professor coordinator, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT02388139    
Other Study ID Numbers: REN-ACS
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy:
acute myocardial infarction
renal artery stenosis
Additional relevant MeSH terms:
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Renal Artery Obstruction
Hypertension, Renovascular
Myocardial Infarction
Infarction
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Hypertension, Renal