Coronary Artery DiseaseNCT02496234
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
An observational study of Coronary Artery Disease, run by Sapere Bio at 1 site in United States.
Trial summary
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects entered into this study will be patients of the Duke University Health System.
Who may be able to join
- Patients must fulfill all criteria to be eligible for this study:
- Adult patients (>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).
Who cannot join
- Patients who fulfill any of the following criteria will be excluded:
- Emergency surgery.
- Off-pump coronary bypass grafting.
- Aortic aneurysm repair.
- Congenital heart disease repair.
- Heart transplant or LVAD patient.
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- Severe heart failure (LVEF<25%).
- Hemodynamic instability or requiring preoperative vasopressors or IABP.
- Pre-existing end-stage kidney disease (eGFR< 15 mL/min/1.73 m2) or renal transplantation.
- Presence of major active infection (chronic or acute, e.g. sepsis, HIV, pneumonia).
- Chronic liver disease /cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft Surgery, Acute kidney injury, Renal failure, Biomarker
- Medical subject headings
- Coronary Artery Disease, Acute Kidney Injury, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline)
Measured: 48-72 hours
Secondary outcomes (13)
Number of Participants who suffered postoperative stroke
Measured: 30 days
Number of Participants who suffered cognitive decline
Measured: 30 days
Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)
Measured: 30 days
Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.
Measured: 30 days
Number of Participants with cardiac arrest
Measured: 30 days
Number of Participants with perioperative myocardial infarction
Measured: 30 days
Number of Participants with perioperative ventricular dysfunction.
Measured: 30 days
Number of Participants with postoperative deep sternal wound infection
Measured: 30 days
Number of Participants with postoperative thoracotomy infection
Measured: 30 days
Number of Participants with postoperative sepsis.
Measured: 30 days
Number of Participants in need for renal replacement therapy
Measured: 30 days
Number of Participants who progressed to end stage renal disease.
Measured: 30 days
Death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapere Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Mihai V Podgoreanu, MD, FASE, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496234
- Sponsor's protocol ID
- HSDX-1503
- Status last verified
- Nov 2016
- First submitted
- 8 Jul 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02496234
- Acronym / sponsor ID
- HSDX-1503
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft Surgery, Acute kidney injury, Renal failure, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Sapere BioIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Jul 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.
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects entered into this study will be patients of the Duke University Health System.
Key inclusion criteria (2 listed)
- Adult patients (>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).
Key exclusion criteria (11 listed)
- Emergency surgery.
- Off-pump coronary bypass grafting.
- Aortic aneurysm repair.
- Congenital heart disease repair.
- Heart transplant or LVAD patient.
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
Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline)
Time frame: 48-72 hours
13 secondary outcomes
Number of Participants who suffered postoperative stroke
Time frame: 30 days
Number of Participants who suffered cognitive decline
Time frame: 30 days
Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)
Time frame: 30 days
Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.
Time frame: 30 days
Number of Participants with cardiac arrest
Time frame: 30 days
Number of Participants with perioperative myocardial infarction
Time frame: 30 days
Number of Participants with perioperative ventricular dysfunction.
Time frame: 30 days
Number of Participants with postoperative deep sternal wound infection
Time frame: 30 days
Number of Participants with postoperative thoracotomy infection
Time frame: 30 days
Number of Participants with postoperative sepsis.
Time frame: 30 days
Number of Participants in need for renal replacement therapy
Time frame: 30 days
Number of Participants who progressed to end stage renal disease.
Time frame: 30 days
Death
Time frame: 1 year
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 23 Nov 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.
Mihai V Podgoreanu, MD, FASE principal investigator
Duke University
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 Coronary Artery Disease, run by Sapere Bio at 1 site 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 2 inclusion and 11 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 23 Nov 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 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.
What does the primary outcome measure?
Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline) (time frame: 48-72 hours). 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 23 Nov 2016.