Cardiovascular Surgery With Coronary AngiographyENCINONCT00693329
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
An observational study of Cardiovascular Surgery With Coronary Angiography, run by Abbott RDx Cardiometabolic at 3 sites in United States.
Trial summary
This is a multi-center clinical study designed to assess the performance of the Triage NGAL test as an aid in the early risk assessment for contrast-induced nephropathy (CIN). Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving administration of iodinated contrast agent(s) will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery With Coronary Angiography
- How many people
- 260 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Dec 2009
- 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: Patients undergoing intra-arterial angiography involving administration of iodinated contrast agent(s).
Who may be able to join
- Males and females 18 years of age or older;
- Undergoing angiographic procedure involving the intra-arterial administration of iodinated contrast agent(s);
- Chronic kidney disease indiacated by an eGFR < 75 ml/min/1.73 m2 based on screening labs performed ≤ 3 months prior to procedure.
- Able and willing to provide written informed consent for study participation and to comply with all study procedures.
Who cannot join
- Renal transplant recipients
- Pre-existing evidence of acute renal failure at the time of enrollment.
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at enrollment.
- Coronary artery bypass surgery or PCI within the previous 30 days.
- Participation in an interventional clinical study with an experimental therapy within the previous 30 days.
- Administration of intravasular contrast within the previous 30 days.
- Undergoing renal artery stenting.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Providence Hospital
Providence, Michigan, 48075
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
This is a multi-center clinical study designed to assess the performance of the Triage NGAL test as an aid in the early risk assessment for contrast-induced nephropathy (CIN). Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving administration of iodinated contrast agent(s) will be enrolled.
Read the detailed description
EDTA anti-coagulated blood samples will be drawn at eight different time points from within 1 hour prior to first contrast administration through 48 hours. These blood samples will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage and testing of Triage NGAL and serum creatinine. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Any additional serum creatinine measurements obtained by the medical team as part of routine care as well as need for dialysis, hospitalization, major adverse cardiovascular events and mortality will be recorded through Day 30.
- Keywords
- Contrast Induced Nephrophathy (CIN), Kidney, NGAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgery With Coronary AngiographyStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Investigators
- Peter McCullough, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693329
- Sponsor's protocol ID
- BSTE-0406
- Acronym
- ENCINO
- Status last verified
- Dec 2009
- First submitted
- 5 Jun 2008
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
- ClinicalTrials.gov ID
- NCT00693329
- Acronym / sponsor ID
- ENCINO / BSTE-0406
- Keywords
- Contrast Induced Nephrophathy (CIN), Kidney, NGAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Jun 2008 (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.
This is a multi-center clinical study designed to assess the performance of the Triage NGAL test as an aid in the early risk assessment for contrast-induced nephropathy (CIN). Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving administration of iodinated contrast agent(s) will be enrolled.
Detailed description
EDTA anti-coagulated blood samples will be drawn at eight different time points from within 1 hour prior to first contrast administration through 48 hours. These blood samples will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage and testing of Triage NGAL and serum creatinine. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Any additional serum creatinine measurements obtained by the medical team as part of routine care as well as need for dialysis, hospitalization, major adverse cardiovascular events and mortality will be recorded through Day 30.
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
- Patients undergoing intra-arterial angiography involving administration of iodinated contrast agent(s).
Key inclusion criteria (4 listed)
- Males and females 18 years of age or older;
- Undergoing angiographic procedure involving the intra-arterial administration of iodinated contrast agent(s);
- Chronic kidney disease indiacated by an eGFR < 75 ml/min/1.73 m2 based on screening labs performed ≤ 3 months prior to procedure.
- Able and willing to provide written informed consent for study participation and to comply with all study procedures.
Key exclusion criteria (7 listed)
- Renal transplant recipients
- Pre-existing evidence of acute renal failure at the time of enrollment.
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at enrollment.
- Coronary artery bypass surgery or PCI within the previous 30 days.
- Participation in an interventional clinical study with an experimental therapy within the previous 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
Related trials for Cardiovascular Surgery With Coronary Angiography
Active, not recruitingObservational study
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended
Coronary Artery Disease
RecruitingObservational study
Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)
Acute Coronary Syndrome, Coronary Bypass Stenosis
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.
Peter McCullough, MD principal investigator
Corewell Health East
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgery With Coronary Angiography, run by Abbott RDx Cardiometabolic at 3 sites in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Dec 2009.