Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction (HYD-AMI)

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

Hydration Status Assessment Through Body Composition Monitoring And Renal Artery Stenosis Evaluation in Patients With Acute Myocardial Infarction Referred For Primary PCI

Aims:

  • evaluate the hydric status through bioimpedance spectroscopy in consecutive acute myocardial infarction patients referred for primary PCI;
  • assessment of renal artery stenosis incidence through renal angiography in consecutive STEMI patients;
  • fully characterize the complex hydration, metabolic and endothelial profile of these patients in the attempt to define the role played by dehydration in the complex dynamics of acute myocardial infarction.

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;
  • metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
  • 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);
  • renal arteries angiographic details performed in the same time with PCI (two independent operators evaluate stenosis based on a predefined scale);
  • renal diameters;
  • measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
  • in-hospital and one month follow-up MACE.

Study Type

Observational

Enrollment (Anticipated)

400

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 Contact Backup

Study Locations

  • Romania
      • Iasi, Romania, 700503
        • Recruiting
        • Cardiovascular Diseases Institute - IASI
        • Contact:

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 consecutive patients admitted with acute myocardial infarction (<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 ST elevation Myocardial Infarction (<12h) diagnostic confirmed;
  • included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

Exclusion Criteria:

  • patients who do not sign informed consent for primary PCI

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consecutive STEMI Patients
All patients with AMI referred for primary PCI in a single centre
Device: Body Composition Monitoring
using Fresenius device; two measurements before and after coronary intervention;
Other Names:
  • BCM
Procedure: Coronarography
Preprocedural coronary arteriography 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 left coronary stem, 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.
Other Names:
  • Coronary Artery Angiography
Procedure: Primary Percutaneous Coronary Intervention
An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
Other Names:
  • Primary PCI
Procedure: Renal Angiography
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. This procedure is performed in the same time with primary PCI
Other Names:
  • RA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)
Time Frame: 2 years
Assessment of hydration status through body composition monitoring BCM before and after coronary intervention
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Artery Stenosis
Time Frame: 2 years
Assessment of renal artery stenosis incidence in consecutive AMI patients;
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: Adrian Covic, Professor, Grigore T. Popa University of Medicine and Pharmacy

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

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

January 14, 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

  • HYD-AMI001

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.

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