Pathological ProcessesPhase 2NCT02681913
Adenosine as an Adjunct to Blood Cardioplegia
A Phase 2 study testing Adenosine in people with Pathological Processes and Cardiomyopathies, run by Amphia Hospital at 1 site in Netherlands.
Trial summary
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pathological Processes, Cardiomyopathies
- What is being tested?
- Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2016to Dec 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective cardiac surgical patients
- minimally invasive, port access surgery (mitral valve surgery)
Who cannot join
- All non-minimally invasive, port access surgery
- Theophylline or dipyridamole use up to 24 hours prior to surgery
- Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amphia Hospital
Breda, North Brabant, 4818CK
Jeffrey Engelhart, PharmD, 0031765954391, jengelhart@amphia.nl
Thierry Scohy, MD, 0031765955570, tscohy@amphia.nl
About this study
Official title: The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia: A Randomized Placebo-controlled Trial
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.
Read the detailed description
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
- Conditions
- Pathological Processes, Cardiomyopathies
- Being tested
- Adenosine
- Keywords
- Cardioplegia, Cardiac Surgery, Adenosine, Therapeutic Uses, Intermittent warm blood cardioplegia, Minimally Invasive Surgery, minimally invasive mitral valve plasty (mini-MPL), minimally invasive mitral valve replacement (mini-MVR)
- Medical subject headings
- Pathologic Processes, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Adenocor
This group receives intermittent warm blood cardioplegia enriched with adenosine
| Study group | Role | What they receive |
|---|---|---|
| standard cardioplegia | No intervention | Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute. The cardioplegic maintenance solution consists of a 500 ml normal saline (0.9% NaCl) infusion bag. Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol. This arms receives standard intermittent 20:1 diluted warm blood cardioplegic solution. Intervention: n/a |
| adenosine enriched cardioplegia | Experimental | Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute.
The cardioplegic maintenance solution consists of a 1000 mg = 500 ml adenosine infusion bag (2 mg/ml). Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol.
This arms receives adenosine enriched, intermittent 20:1 diluted warm blood cardioplegic solution.
Intervention: Drug: Adenosine Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-hour cardiac Troponin T (cTnT) release
The primary end point is 6-hour cTnT release
Measured: 6 hours post-operative
Secondary outcomes (12)
18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release
18-hour postoperative AUC release of cardiac troponin T Routine blood samples pre-operatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2), and 18 hours after arrival at ICU (T3).
Measured: cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival
Incidence of myocardial injury on 12-lead ECG
Incidence of myocardial injury on 12-lead ECG
- New-onset Left bundle branch block (LBBB)
- New-onset Q wave
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Vasoactive-inotropic score
The hourly doses of the following inotropic and vasoactive medications are recorded for the first 18 h after post-operative admission to the ICU: dopamine, dobutamine, epinephrine, norepinephrine, milrinone and vasopressin.
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Vasoconstrictor usage
Vasoconstrictor usage yes/no
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Incidence of new onset Atrial fibrillation (AF)
Incidence of new onset AF
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Routine blood samples
The amount of creatine kinase MB (CK-MB) and Creatinine at different time intervals. preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2)
Measured: Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival
Mean arterial pressure (MAP)
Haemodynamic monitoring
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
postoperative left ventricular ejection fraction (LVEF)
3-D transesophageal echocardiography (TEE) postoperative left ventricular ejection fraction (LVEF) after skin closure
Measured: postoperative after skin closure, an expected average of 3 hours after starting surgery
Wall Motion Score Index (WMSI)
3-D transesophageal echocardiography (TEE) Wall Motion Score Index (WMSI) after skin closure
Measured: postoperative after skin closure, an expected average of 3 hours after starting surgery
Heart rate (HR)
Haemodynamic monitoring. Heart rate will be measured in beats per minute (bpm).
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Cardiac index (CI)
Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA)
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Systemic vascular resistance index (SVRI)
SVRI = 80 x (MAP - RAP)/CI MAP = Mean Arterial Pressure (mmHg) RAP = Right Arterial Pressure (mmHg) CI = Cardiac Index (L/min/m2)
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pathological ProcessesStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Engelhart, Amphia Hospital
- Investigators
- Jeffrey Engelhart, PharmD, Principal investigator, Amphia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681913
- Sponsor's protocol ID
- 1437
- Other IDs
- 2015-001923-22, 2015
- Status last verified
- Apr 2017
- First submitted
- 3 Feb 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahlsson A, Sobrosa C, Kaijser L, Jansson E, Bomfim V. Adenosine in cold blood cardioplegia--a placebo-controlled study. Interact Cardiovasc Thorac Surg. 2012 Jan;14(1):48-55. doi: 10.1093/icvts/ivr027. Epub 2011 Nov 15.
PubMed 22108937Cohen G, Feder-Elituv R, Iazetta J, Bunting P, Mallidi H, Bozinovski J, Deemar C, Christakis GT, Cohen EA, Wong BI, McLean RD, Myers M, Morgan CD, Mazer CD, Smith TS, Goldman BS, Naylor CD, Fremes SE. Phase 2 studies of adenosine cardioplegia. Circulation. 1998 Nov 10;98(19 Suppl):II225-33.
PubMed 9852907Cohen G, Borger MA, Weisel RD, Rao V. Intraoperative myocardial protection: current trends and future perspectives. Ann Thorac Surg. 1999 Nov;68(5):1995-2001. doi: 10.1016/s0003-4975(99)01026-7.
PubMed 10585118Chauhan S, Wasir HS, Bhan A, Rao BH, Saxena N, Venugopal P. Adenosine for cardioplegic induction: a comparison with St Thomas solution. J Cardiothorac Vasc Anesth. 2000 Feb;14(1):21-4. doi: 10.1016/s1053-0770(00)90050-8.
PubMed 10698387Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.
PubMed 10235522Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.
PubMed 22795715Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
PubMed 22964356Liu R, Xing J, Miao N, Li W, Liu W, Lai YQ, Luo Y, Ji B. The myocardial protective effect of adenosine as an adjunct to intermittent blood cardioplegia during open heart surgery. Eur J Cardiothorac Surg. 2009 Dec;36(6):1018-23. doi: 10.1016/j.ejcts.2009.06.033. Epub 2009 Aug 15.
PubMed 19683936
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02681913
- Acronym / sponsor ID
- 1437
- Conditions
- Pathological Processes, Cardiomyopathies
- Keywords
- Cardioplegia, Cardiac Surgery, Adenosine, Therapeutic Uses, Intermittent warm blood cardioplegia, Minimally Invasive Surgery, minimally invasive mitral valve plasty (mini-MPL), minimally invasive mitral valve replacement (mini-MVR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Feb 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.
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.
Detailed description
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard cardioplegia | No intervention | –Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute. The cardioplegic maintenance solution consists of a 500 ml normal saline (0.9% NaCl) infusion bag. Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol. This arms receives standard intermittent 20:1 diluted warm blood cardioplegic solution. Intervention: n/a |
| adenosine enriched cardioplegia | Experimental | Drug: AdenosineDelivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute. The cardioplegic maintenance solution consists of a 1000 mg = 500 ml adenosine infusion bag (2 mg/ml). Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol. This arms receives adenosine enriched, intermittent 20:1 diluted warm blood cardioplegic solution. Intervention: Drug: Adenosine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective cardiac surgical patients
Key exclusion criteria (3 listed)
- All non-minimally invasive, port access surgery
- Theophylline or dipyridamole use up to 24 hours prior to surgery
- Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)
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 |
|---|---|---|
| AdenosineAlso: AdenocorThis group receives intermittent warm blood cardioplegia enriched with adenosine | Drug | adenosine enriched cardioplegia |
Primary outcome
6-hour cardiac Troponin T (cTnT) release
Time frame: 6 hours post-operative
The primary end point is 6-hour cTnT release
12 secondary outcomes
18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release
Time frame: cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival
Incidence of myocardial injury on 12-lead ECG
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Vasoactive-inotropic score
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Vasoconstrictor usage
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Incidence of new onset Atrial fibrillation (AF)
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Routine blood samples
Time frame: Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival
Mean arterial pressure (MAP)
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
postoperative left ventricular ejection fraction (LVEF)
Time frame: postoperative after skin closure, an expected average of 3 hours after starting surgery
Wall Motion Score Index (WMSI)
Time frame: postoperative after skin closure, an expected average of 3 hours after starting surgery
Heart rate (HR)
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Cardiac index (CI)
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Systemic vascular resistance index (SVRI)
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Background: PubMed 22108937Ahlsson A, Sobrosa C, Kaijser L, Jansson E, Bomfim V. Adenosine in cold blood cardioplegia--a placebo-controlled study. Interact Cardiovasc Thorac Surg. 2012 Jan;14(1):48-55. doi: 10.1093/icvts/ivr027. Epub 2011 Nov 15.
- Background: PubMed 9852907Cohen G, Feder-Elituv R, Iazetta J, Bunting P, Mallidi H, Bozinovski J, Deemar C, Christakis GT, Cohen EA, Wong BI, McLean RD, Myers M, Morgan CD, Mazer CD, Smith TS, Goldman BS, Naylor CD, Fremes SE. Phase 2 studies of adenosine cardioplegia. Circulation. 1998 Nov 10;98(19 Suppl):II225-33.
- Background: PubMed 10585118Cohen G, Borger MA, Weisel RD, Rao V. Intraoperative myocardial protection: current trends and future perspectives. Ann Thorac Surg. 1999 Nov;68(5):1995-2001. doi: 10.1016/s0003-4975(99)01026-7.
- Background: PubMed 10698387Chauhan S, Wasir HS, Bhan A, Rao BH, Saxena N, Venugopal P. Adenosine for cardioplegic induction: a comparison with St Thomas solution. J Cardiothorac Vasc Anesth. 2000 Feb;14(1):21-4. doi: 10.1016/s1053-0770(00)90050-8.
- Background: PubMed 10235522Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.
- Background: PubMed 22795715Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.
- Background: PubMed 22964356Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
- Background: PubMed 19683936Liu R, Xing J, Miao N, Li W, Liu W, Lai YQ, Luo Y, Ji B. The myocardial protective effect of adenosine as an adjunct to intermittent blood cardioplegia during open heart surgery. Eur J Cardiothorac Surg. 2009 Dec;36(6):1018-23. doi: 10.1016/j.ejcts.2009.06.033. Epub 2009 Aug 15.
- Individual participant dataSharing planned: No
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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.
Jeffrey Engelhart, PharmD principal investigator
Amphia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adenosine in people with Pathological Processes and Cardiomyopathies, run by Amphia Hospital at 1 site in Netherlands.
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 3 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 20 Apr 2017. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jeffrey Engelhart, PharmD (0031765954391, JEngelhart@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-hour cardiac Troponin T (cTnT) release (time frame: 6 hours post-operative). 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 NCT02681913, which also lists 8 linked publications.
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 20 Apr 2017.