DehydrationHYD-AMINCT02655341
Hydration Status Assessment Through Body Composition Monitoring in Patients With Acute Myocardial Infarction
An observational study of Dehydration and Acute Myocardial Infarction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration, Acute Myocardial Infarction, Renal Artery Stenosis
- What is being tested?
- Body Composition Monitoring, Coronarography and Primary Percutaneous Coronary Intervention
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2016to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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;
Who may be able to join
- 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);
Who cannot join
- patients who do not sign informed consent for primary PCI
Trial locations and contacts
1 site in 1 country.
Adrian Covic, Professor contact
Romania1 site, 1 recruiting
- Recruiting
Cardiovascular Diseases Institute - IASI
Iași, Iaşi, 700503
Alexandru Burlacu, MD, 0040744488580, alburlacu@yahoo.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Body Composition Monitoring, Coronarography, Primary Percutaneous Coronary Intervention, Renal Angiography
- Keywords
- Dehydration, Primary PCI, Acute Myocardial Infarction, Bioimpedance, Renal Angiography
- Medical subject headings
- Dehydration, Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Composition MonitoringDevice
Also called BCM
using Fresenius device; two measurements before and after coronary intervention;
CoronarographyProcedure or surgery
Also called Coronary Artery Angiography
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.
Primary Percutaneous Coronary InterventionProcedure or surgery
Also called Primary PCI
An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
Renal AngiographyProcedure or surgery
Also called RA
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
| Study group | Role | What they receive |
|---|---|---|
| Consecutive STEMI Patients | All patients with AMI referred for primary PCI in a single centre Receives: Device: Body Composition Monitoring; Procedure: Coronarography; Procedure: Primary Percutaneous Coronary Intervention; Procedure: Renal Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Renal Artery Stenosis
Assessment of renal artery stenosis incidence in consecutive AMI patients;
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Adrian Covic, Professor, Principal investigator, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655341
- Sponsor's protocol ID
- HYD-AMI001
- Acronym
- HYD-AMI
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration Status Assessment Through Body Composition Monitoring And Renal Artery Stenosis Evaluation in Patients With Acute Myocardial Infarction Referred For Primary PCI
- ClinicalTrials.gov ID
- NCT02655341
- Acronym / sponsor ID
- HYD-AMI / HYD-AMI001
- Keywords
- Dehydration, Primary PCI, Acute Myocardial Infarction, Bioimpedance, Renal Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive STEMI Patients | – | Device: Body Composition Monitoring, Procedure: Coronarography, Procedure: Primary Percutaneous Coronary Intervention, Procedure: Renal AngiographyAll patients with AMI referred for primary PCI in a single centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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;
Key inclusion criteria (2 listed)
- 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);
Key exclusion criteria (1 listed)
- patients who do not sign informed consent for primary PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Composition MonitoringAlso: BCMusing Fresenius device; two measurements before and after coronary intervention; | Device | Consecutive STEMI Patients |
| CoronarographyAlso: Coronary Artery AngiographyPreprocedural 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. | Procedure or surgery | Consecutive STEMI Patients |
| Primary Percutaneous Coronary InterventionAlso: Primary PCIAn intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty. | Procedure or surgery | Consecutive STEMI Patients |
| Renal AngiographyAlso: RAAfter 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 | Procedure or surgery | Consecutive STEMI Patients |
Primary outcome
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
1 secondary outcome
Renal Artery Stenosis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Covic, Professor contact
Adrian Covic, Professor principal investigator
Grigore T. Popa University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration and Acute Myocardial Infarction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandru Burlacu, M.D. (0040744488580, alburlacu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydration Status in Acute Myocardial Infarction Patients (before and after p PCI) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.