Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction
HYD-AMI
1 other identifier
observational
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 14, 2016
January 1, 2016
1 year
January 12, 2016
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI)
Assessment of hydration status through body composition monitoring BCM before and after coronary intervention
2 years
Secondary Outcomes (1)
Renal Artery Stenosis
2 years
Study Arms (1)
Consecutive STEMI Patients
All patients with AMI referred for primary PCI in a single centre
Interventions
using Fresenius device; two measurements before and after coronary intervention;
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.
An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
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
Eligibility Criteria
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;
You may qualify if:
- 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);
You may not qualify if:
- patients who do not sign informed consent for primary PCI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Diseases Institute - IASI
Iași, Iaşi, 700503, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Covic, Professor
Grigore T. Popa University of Medicine and Pharmacy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Adrian Covic, MD, PhD
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 14, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
January 14, 2016
Record last verified: 2016-01