Hypertension, RenovascularREN-ACSNCT02388139
Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (REN-ACS)
An observational study of Hypertension, Renovascular and Renal Artery Stenosis, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renovascular, Renal Artery Stenosis, Myocardial Infarction
- What is being tested?
- renal artery angiography, coronarography and coronary angioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2014to Jun 2017
- 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 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;
Who may be able to join
- adults with AMI (<12h) diagnostic confirmed;
- included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Alexandru Burlacu, MD contact
Romania1 site, 1 recruiting
- Recruiting
Cardiology Departament "IBCV" Hospital
Iași, 700503
Alexandru Burlacu, MD, alburlacu@yahoo.com
Alexandru Burlacu, MD
About this study
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
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.
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 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;
- Being tested
- renal artery angiography, coronarography, coronary angioplasty, pulse wave velocity measurement, body composition monitoring
- Keywords
- acute myocardial infarction, renal artery stenosis
- Medical subject headings
- Hypertension, Renovascular, Renal Artery Obstruction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal artery angiographyProcedure or surgery
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.
coronarographyProcedure or surgery
coronary angioplastyProcedure or surgery
Also called pPCI
pulse wave velocity measurementProcedure or surgery
Also called PWV
is a measure of arterial stiffness with Sphigmocore device.
body composition monitoringProcedure or surgery
Also called BCM
using Fresenius device
What is being measured
The primary outcome is the main question the study is designed to answer.
renal artery stenosis incidence
assessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;
Measured: 2 years
Secondary outcomes (1)
cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
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 posted13 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, RenovascularStudies 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
- 200 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
- Alexandru Burlacu, MD, Principal investigator, University of Medicine and Pharmacy "Gr T Popa" Iasi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388139
- Sponsor's protocol ID
- REN-ACS
- Acronym
- REN-ACS
- Status last verified
- Jan 2016
- First submitted
- 9 Mar 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Burlacu A, Siriopol D, Voroneanu L, Nistor I, Hogas S, Nicolae A, Nedelciuc I, Tinica G, Covic A. Atherosclerotic Renal Artery Stenosis Prevalence and Correlations in Acute Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Interventions: Data From Nonrandomized Single-Center Study (REN-ACS)-A Single Center, Prospective, Observational Study. J Am Heart Assoc. 2015 Oct 12;4(10):e002379. doi: 10.1161/JAHA.115.002379.
PubMed 26459932
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02388139
- Acronym / sponsor ID
- REN-ACS / REN-ACS
- Keywords
- acute myocardial infarction, renal artery stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Mar 2015 (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
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
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 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;
Key inclusion criteria (2 listed)
- adults with AMI (<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)
- none
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 |
|---|---|---|
| renal artery angiographypreprocedural 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 or surgery | – |
| coronarography | Procedure or surgery | – |
| coronary angioplastyAlso: pPCI | Procedure or surgery | – |
| pulse wave velocity measurementAlso: PWVis a measure of arterial stiffness with Sphigmocore device. | Procedure or surgery | – |
| body composition monitoringAlso: BCMusing Fresenius device | Procedure or surgery | – |
Primary outcome
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;
1 secondary outcome
cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
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 13 Jan 2016.
- Derived from this study: PubMed 26459932Burlacu A, Siriopol D, Voroneanu L, Nistor I, Hogas S, Nicolae A, Nedelciuc I, Tinica G, Covic A. Atherosclerotic Renal Artery Stenosis Prevalence and Correlations in Acute Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Interventions: Data From Nonrandomized Single-Center Study (REN-ACS)-A Single Center, Prospective, Observational Study. J Am Heart Assoc. 2015 Oct 12;4(10):e002379. doi: 10.1161/JAHA.115.002379.
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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.
Alexandru Burlacu, MD contact
Alexandru Burlacu, MD principal investigator
University of Medicine and Pharmacy "Gr T Popa" Iasi
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 Hypertension, Renovascular and Renal Artery Stenosis, 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 13 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, MD (alburlacu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal artery stenosis incidence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388139, which also lists 1 linked publication.
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 13 Jan 2016.