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

January 12, 2016 updated by: Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Iasi, Romania, 700503
        • Recruiting
        • Cardiology Departament "IBCV" Hospital
        • Contact:
        • Principal Investigator:
          • Alexandru Burlacu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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;

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Alexandru Burlacu, MD, University of Medicine and Pharmacy "Gr T Popa" Iasi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REN-ACS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on renal artery angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe