Contrast-induced NephropathyNCT04163250
Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography
An observational study of Contrast-induced Nephropathy, run by Eva de Miguel Balsa at 1 site in Spain.
Trial summary
Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Urinary determination of TIMP-2/ IGFBP7
- How many people
- 194 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Mar 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 21 years, with moderate / high risk acute coronary syndrome according to GRACE score and exposed to intra-arterial iodinated contrast media
Who may be able to join
- Patients older than 21 years exposed to intra-arterial iodinated contrast media for diagnostic / therapeutic purposes and who have signed the Informed Consent document.
Who cannot join
- Patients who have been exposed to a previous dose of iodinated contrast within 72 hours prior to recruitment.
- Patients with urgent radiodiagnostic intervention criteria, when it is not possible to obtain a previous urine sample without delaying the diagnosis and / or the intervention.
- Patients in anuria.
- Patients with chronic kidney disease, treated with hemodialysis (HD) or peritoneal dialysis.
- Bilirubinuria: bilirubin concentrations in the urine> 7.2 g / dL interfere with the result.
- Patients in terminal situations, in which diagnostic and therapeutic tests are limited.
- Patients under 21 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Urinary TIMP-2/ IGFBP7 in Intra-Arterial Contrast-Associated Acute Kidney Injury
Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing.
IC can cause kidney damage, so there is caution in their use in at-risk populations. This fact may limit its diagnostic use, with data on underutilization of interventional techniques in patients with renal insufficiency, which worsen their prognosis.
Read more
In addition, once the use of IC contrasts is decided, preventive measures, such as hyperhydration,are used and can have potential side effects, especially in patients at risk of heart failure (acute coronary syndrome, low left ventricular ejection fraction).
New biomarkers of kidney damage have recently been developed, based on the detection of molecules expressed by the kidney in situations of early damage. The quantitative determination of cell cycle arrest proteins (Tissue Inhibitor of metalloproteinase 2 (TIMP2) and Insulin-Like Growth Factor Binding Protein -7 (IGFBP7)) can be predictive of the development of moderate to severe contrast-associated acute kidney injury.
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS (acute coronary syndromes) before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures.
Read the detailed description
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS undergoing cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of both appropriate preventive measures.
A prospective, descriptive observational study will be carried out to determine sensitivity and specificity of the urinary determination of TIMP2-IGFBP7 and predictive values in the early diagnosis of contrast-associated acute kidney injury (AKI) in patients admitted to the Coronary Care Unit (CCU) in a spanish hospital.
OBJECTIVES
- PRIMARY OBJECTIVE: To determine the operational characteristics (sensitivity, specificity) of the TIMP2-IGFBP7 biomarker in routine clinical practice, in the early diagnosis of contrast-induced AKI (acute renal injury) in patients admitted to the CCU, exposed to iodinated contrasts. The established renal failure is defined as KDIGO (Kidney Disease Improving Global Outcomes) stage ≥ 2 in the 24 to 72 hours after the administration of contrasts.
- SECONDARY OBJECTIVES
Evaluate these parameters according to the patient's initial risk level:
- Estimated renal function upon admission
- Initial severity estimated by GRACE score
- Sex
- Age
- Contrast media type and volume
- Patient weight
- Dose of contrast
- Diabetes
A single determination (10 ml of fresh urine) should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. Neither the attending physicians nor the investigators will know the results, and the treatment will not be influenced.
The result is reported as a single value which is the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without any unit or concentrations of individual biomarkers. As previously reported, a value of> 0.3 identifies patients with a high probability of presenting a moderate to severe AKI (acute kidney injury) in 12 hours, while a value of ≤ 0.3 identifies patients with a low risk of developing a moderate to serious AKI
An aliquot of urine will be stored at -80 ° C in the Clinical Analysis Department
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Urinary determination of TIMP-2/ IGFBP7
- Keywords
- Contrast media, Urinary cell-cycle arrest biomarkers, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary determination of TIMP-2/ IGFBP7Diagnostic test
Urinary determination of TIMP2-IGFBP7 in the an urine sample obtained within 12 hours prior to contrast administration. A single determination will be made, which will be sent to the laboratory. The doctor who treats the patient will not know the result of the test, and the treatment will not be influenced by the result.
According to the manufacturer, 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection.
The result is reported as a single value calculated as the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without units.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ACS undergoing cardiac catheterization | Adults with moderate / high risk acute coronary syndrome undergoing coronary intervention.
The sample will be selected consecutively, including patients admitted to the Cardiac Coronary Unit and who require a radiological test with intra-arterial IC administration, for diagnostic or diagnostic / therapeutic purposes Receives: Diagnostic Test: Urinary determination of TIMP-2/ IGFBP7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-Associated Acute Kidney Injury
Absolute increase of 0.3 mg / dl in the creatinine value and / or a relative increase greater than 1.5 times the baseline creatinine value, measured at 48 and 72 hours after exposure to contrast.
Measured: up to 72 hours of exposure
Secondary outcomes (2)
Mortality
Patients who die during their hospital stay for any reason
Measured: up to 30 days
Need of renal replacement techniques
Hemodialysis, peritoneal dialysis or continuous renal replacement techniques,
Measured: From exposure to contrasts to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Jun 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva de Miguel Balsa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva de Miguel Balsa, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163250
- Sponsor's protocol ID
- GV/2019/003
- Status last verified
- Aug 2021
- First submitted
- 10 Nov 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Urinary TIMP-2/ IGFBP7 in Intra-Arterial Contrast-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04163250
- Acronym / sponsor ID
- GV/2019/003
- Conditions
- Contrast-induced Nephropathy
- Keywords
- Contrast media, Urinary cell-cycle arrest biomarkers, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Eva de Miguel BalsaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- 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.
Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing.
IC can cause kidney damage, so there is caution in their use in at-risk populations. This fact may limit its diagnostic use, with data on underutilization of interventional techniques in patients with renal insufficiency, which worsen their prognosis.
In addition, once the use of IC contrasts is decided, preventive measures, such as hyperhydration,are used and can have potential side effects, especially in patients at risk of heart failure (acute coronary syndrome, low left ventricular ejection fraction).
New biomarkers of kidney damage have recently been developed, based on the detection of molecules expressed by the kidney in situations of early damage. The quantitative determination of cell cycle arrest proteins (Tissue Inhibitor of metalloproteinase 2 (TIMP2) and Insulin-Like Growth Factor Binding Protein -7 (IGFBP7)) can be predictive of the development of moderate to severe contrast-associated acute kidney injury.
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS (acute coronary syndromes) before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures.
Detailed description
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS undergoing cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of both appropriate preventive measures.
A prospective, descriptive observational study will be carried out to determine sensitivity and specificity of the urinary determination of TIMP2-IGFBP7 and predictive values in the early diagnosis of contrast-associated acute kidney injury (AKI) in patients admitted to the Coronary Care Unit (CCU) in a spanish hospital.
OBJECTIVES
- PRIMARY OBJECTIVE: To determine the operational characteristics (sensitivity, specificity) of the TIMP2-IGFBP7 biomarker in routine clinical practice, in the early diagnosis of contrast-induced AKI (acute renal injury) in patients admitted to the CCU, exposed to iodinated contrasts. The established renal failure is defined as KDIGO (Kidney Disease Improving Global Outcomes) stage ≥ 2 in the 24 to 72 hours after the administration of contrasts.
- SECONDARY OBJECTIVES
Evaluate these parameters according to the patient's initial risk level:
- Estimated renal function upon admission
- Initial severity estimated by GRACE score
- Sex
- Age
- Contrast media type and volume
- Patient weight
- Dose of contrast
- Diabetes
A single determination (10 ml of fresh urine) should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. Neither the attending physicians nor the investigators will know the results, and the treatment will not be influenced.
The result is reported as a single value which is the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without any unit or concentrations of individual biomarkers. As previously reported, a value of> 0.3 identifies patients with a high probability of presenting a moderate to severe AKI (acute kidney injury) in 12 hours, while a value of ≤ 0.3 identifies patients with a low risk of developing a moderate to serious AKI
An aliquot of urine will be stored at -80 ° C in the Clinical Analysis Department
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ACS undergoing cardiac catheterization | – | Diagnostic Test: Urinary determination of TIMP-2/ IGFBP7Adults with moderate / high risk acute coronary syndrome undergoing coronary intervention. The sample will be selected consecutively, including patients admitted to the Cardiac Coronary Unit and who require a radiological test with intra-arterial IC administration, for diagnostic or diagnostic / therapeutic purposes |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 21 years, with moderate / high risk acute coronary syndrome according to GRACE score and exposed to intra-arterial iodinated contrast media
Key inclusion criteria (1 listed)
- Patients older than 21 years exposed to intra-arterial iodinated contrast media for diagnostic / therapeutic purposes and who have signed the Informed Consent document.
Key exclusion criteria (7 listed)
- Patients who have been exposed to a previous dose of iodinated contrast within 72 hours prior to recruitment.
- Patients with urgent radiodiagnostic intervention criteria, when it is not possible to obtain a previous urine sample without delaying the diagnosis and / or the intervention.
- Patients in anuria.
- Patients with chronic kidney disease, treated with hemodialysis (HD) or peritoneal dialysis.
- Bilirubinuria: bilirubin concentrations in the urine> 7.2 g / dL interfere with the result.
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 |
|---|---|---|
| Urinary determination of TIMP-2/ IGFBP7Urinary determination of TIMP2-IGFBP7 in the an urine sample obtained within 12 hours prior to contrast administration. A single determination will be made, which will be sent to the laboratory. The doctor who treats the patient will not know the result of the test, and the treatment will not be influenced by the result. According to the manufacturer, 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. The result is reported as a single value calculated as the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without units. | Diagnostic test | Patients with ACS undergoing cardiac catheterization |
Primary outcome
Contrast-Associated Acute Kidney Injury
Time frame: up to 72 hours of exposure
Absolute increase of 0.3 mg / dl in the creatinine value and / or a relative increase greater than 1.5 times the baseline creatinine value, measured at 48 and 72 hours after exposure to contrast.
2 secondary outcomes
Mortality
Time frame: up to 30 days
Need of renal replacement techniques
Time frame: From exposure to contrasts to three months
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 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Contrast-induced Nephropathy, run by Eva de Miguel Balsa at 1 site in Spain.
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 1 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 17 Aug 2021. 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 Spain. 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.
What does the primary outcome measure?
Contrast-Associated Acute Kidney Injury (time frame: up to 72 hours of exposure). 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 17 Aug 2021.