Coronary Artery BypassPhase 3NCT04560309
Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
A Phase 3 study testing L-alanyl-L-glutamine dipeptide in people with Coronary Artery Bypass and Cardiopulmonary Bypass, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting (CABG) is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Cardiopulmonary Bypass, Coronary Artery Disease
- What is being tested?
- L-alanyl-L-glutamine dipeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2021to 23 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients with coronary heart disease indicated for elective coronary artery bypass grafting under cardiopulmonary bypass
- Patients with left ventricle ejection fraction 31% -50% confirmed by echocardiography or radio nuclear study.
- Patients age ≥18 years
- Never had heart surgery before
- Agree to participate in the study and signed informed consent
Who cannot join
- Emergency coronary artery grafting bypass
- Having additional procedures other than coronary artery bypass grafting
- History of myocardial infarction with onset less than 3 months
- Patients with serum creatinine level more than 2 g/dL
- Patients with ALT/AST levels more than 1.5 times the upper limit of normal value
- Required to use intra-aortic balloon pump pre-operatively
Show all 17Show fewer
- History of stroke with onset less than 3 months
- History of pre-operative atrial fibrillation
- History of heart conduction problem and/or using a pacemaker
- Patients with HIV
- Contraindications to pulmonary artery catheter insertion
- Drop out Criteria
- Experiencing stroke after surgery
- Experiencing surgery related complication (haemorrhage) requiring re operation
- Requiring continuous veno-venous hemofiltration or haemodialysis after surgery
- Delayed sternal closure
- Aortic cross clamp duration more than 120 minutes and/or cardiopulmonary bypass time more than 180 minutes
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Hospital Indonesia
Jakarta, 11420
About this study
Official title: Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction
Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting (CABG) is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart. Despite of improvement in operation techniques, cardioplegia, cardiopulmonary bypass (CPB), myocardial injury related to on-pump CABG is still prominent. In patient with low ejection fraction undergone on-pump CABG, myocardial injury is related to worse outcome and prognosis during peri-operative and post-operative period. On-pump CABG patients with low ejection fraction has increased (up to four times higher) post-operative in hospital mortality rate compared to patient with normal ejection fraction. Administration of intravenous glutamine had been documented in reducing myocardial damage during cardiac surgery and previous studies indicated that glutamine can protect against myocardial injury by various mechanism during ischemia and reperfusion. The purpose of this study to determine whether intravenous glutamine could prevent the decline of plasma glutamine level, reduce myocardial damage, improve hemodynamic profile, and reduce morbidity of on-pump CABG in patients with low ejection fraction.
Read the detailed description
The study was a double-blind randomized controlled trial to assess the role of glutamine as a myocardial protection during coronary artery bypass grafting under cardiopulmonary bypass in patients with left ventricle ejection fraction of 31-50%. This study was approved by Institutional Review Board of National Cardiovascular Center Harapan Kita and informed consent was obtained before randomization for patient eligible for this study. Allocation of participant to the treatment group was done by block randomization by staff who was not involved in the study. The intervention drug was prepared by pharmacist who also was not involved in the study. Glutamine solution was supplied as L-alanyl-L-glutamine dipeptide (Dipeptiven, 200 mg/mL, Fresenius Kabi, Bad Homburg, Germany) and was prepared to contain 0.5gr/kgbw glutamine diluted in NaCl 0.9% to a final volume of 500 mL. Placebo was supplied as 500 ml of NaCl 0.9%, prepared in similar fashion and packaging as glutamine solution. Principal investigator, care provider, outcome assessor, and participant were blinded to the assigned group until after the end of the study.
Baseline participant characteristics were collected before the intervention included age, sex, body weight, body height, body mass index, and documented pre-operative left ventricle ejection fraction. Coronary artery bypass grafting and cardiopulmonary bypass was done in concordance to standard operating procedure in National Cardiovascular Center Harapan Kita, followed by transit time flow meter measurement to ensure quality of the graft. Modifying factor of the study, the investigators measured duration of surgery, duration of cardiopulmonary bypass, and duration of aortic cross clamp.
The primary outcome of the study was plasma troponin I level. The investigators anticipated plasma troponin I level difference of 20% with standard deviation of 0.04 ng/mL, and for statistical power of 80% and level of significance of 0.05, the required sample size was 24.5 participants per group. As anticipation for participant drop out, the investigators planned to recruit a total of 60 participants.
- Being tested
- L-alanyl-L-glutamine dipeptide, Placebo
- Keywords
- Glutamine, Myocardial protection, Coronary artery bypass grafting, Cardiopulmonary bypass, Low ejection fraction, Myocardial injury
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-alanyl-L-glutamine dipeptideDrug
Also called Dipeptiven
Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
PlaceboDrug
Also called Normal saline
Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw Receives: Drug: L-alanyl-L-glutamine dipeptide |
| Control | Placebo comparator | Intravenous NaCl 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Troponin I at Baseline
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Measured: Before induction to anesthesia
Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Measured: 5 minute after cardiopulmonary bypass
Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Measured: 6 hour after cardiopulmonary bypass
Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Measured: 24 hour after cardiopulmonary bypass
Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Measured: 48 hour after cardiopulmonary bypass
Plasma Glutamine at Baseline
Plasma glutamine were measured using colorimetric tests in unit of µmol/L
Measured: Before induction to anesthesia
Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass
Plasma glutamine were measured using colorimetric tests in unit of µmol/L
Measured: 24 hour after cardiopulmonary bypass
Secondary outcomes (15)
Right Atrial Appendage Alpha-ketoglutarate
Right atrial appendage alpha-ketoglutarate were measured from right atrial appendage tissue biopsy using colorimetric tests in unit of g/mol.
Measured: 5 minute after cardiopulmonary bypass
Right Atrial Appendage Myocardial Injury Score
Right atrial appendage myocardial injury score were measured from tissue section stained with hematoxylin-eosin and examined under by light microscopy in score of 0 (no change) to 3 (major changes with necrosis and diffuse inflammation). Higher scores mean worse outcome
Measured: 5 minute after cardiopulmonary bypass
Right Atrial Appendage Apoptosis Index
Right atrial appendage apoptosis index were measured from tissue section stained with in situ terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) and examined under light microscopy in average number of apoptotic cells (positively stained) from 6 random fields per section
Measured: 5 minute after cardiopulmonary bypass
Anti Cardiac Troponin I Expression
Right atrial appendage anti cardiac troponin I expression were measured from tissue section stained with anti-cardiac troponin I antibody and examined under light microscopy in score of 0 (no change) to -3 (no area observed with anti-cardiac troponin I expression). Higher score mean better outcome
Measured: 5 minute after cardiopulmonary bypass
Ejection Fraction
Ejection fraction were measured by transesophageal echocardiography using Simpson method in percentage (%)
Measured: Immediately after induction of anesthesia
Ejection Fraction
Ejection fraction were measured by transesophageal echocardiography using Simpson method in percentage (%)
Measured: 5 minutes after cardiopulmonary bypass
Cardiac Index
Cardiac index were measured from pulmonary artery catheter using thermodilution method in unit of L/min/m^2
Measured: Immediately after induction of anesthesia, 5 minute, 2 hour, 6 hour, 24 hour after cardiopulmonary bypass
Plasma Lactate Before Induction to Anesthesia
Plasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Measured: Before induction to anesthesia
Plasma Lactate 5 Minute After Cardiopulmonary Bypass
Plasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Measured: 5 minute after cardiopulmonary bypass
Plasma Lactate 6 Hours After Cardiopulmonary Bypass
Plasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Measured: 6 hours after cardiopulmonary bypass
Plasma Lactate 24 Hours After Cardiopulmonary Bypass
Plasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Measured: 24 hours after cardiopulmonary bypass
Plasma Lactate 48 Hours After Cardiopulmonary Bypass
Plasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Measured: 48 hours after cardiopulmonary bypass
Intensive Care Unit Ventilation Time
Intensive care unit ventilation time were measured from length of time participant was on ventilator in intensive care unit in minutes.
Measured: 28 days (or until hospital discharge)
Intensive Care Unit Length of Stay
Intensive care unit length of stay were measured from length of time participant spent in intensive care unit in unit of hours
Measured: 28 days (or until hospital discharge)
Vasoactive Inotropic Score
Vasoactive inotropic score (VIS) were maximum vasoactive and inotropic dose required by participant after surgery measured by VIS=dopamine dose in mg/kgbw/min + dobutamine dose in mg/kgbw/min + 100 x epinephrine dose in mg/kgbw/min + 10 x milrinone dose in mcg/kgbw/min + 10.000 x vasopressin dose in units/kgbw/min + 100 x norepinephrine dose in mcg/kgbw/min. Higher scores means worse outcomes. VIS >= 20 is considered as high VIS and is associated with poor outcomes.
Measured: 28 days (or until hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jan 2021
- Primary completion30 Oct 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery BypassStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Made Adi Parmana, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- I Made Adi Parmana, Principal investigator, National Cardiovascular Center Harapan Kita Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560309
- Sponsor's protocol ID
- LB.02.01/VII/466/KEP059/202
- Other IDs
- LB.02.01/VII/466/KEP059/202
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2020
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data reported in this study will be made available on request after publication and ending 36 months following article publication. Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction
- ClinicalTrials.gov ID
- NCT04560309
- Acronym / sponsor ID
- LB.02.01/VII/466/KEP059/202
- Keywords
- Glutamine, Myocardial protection, Coronary artery bypass grafting, Cardiopulmonary bypass, Low ejection fraction, Myocardial injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting (CABG) is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart. Despite of improvement in operation techniques, cardioplegia, cardiopulmonary bypass (CPB), myocardial injury related to on-pump CABG is still prominent. In patient with low ejection fraction undergone on-pump CABG, myocardial injury is related to worse outcome and prognosis during peri-operative and post-operative period. On-pump CABG patients with low ejection fraction has increased (up to four times higher) post-operative in hospital mortality rate compared to patient with normal ejection fraction. Administration of intravenous glutamine had been documented in reducing myocardial damage during cardiac surgery and previous studies indicated that glutamine can protect against myocardial injury by various mechanism during ischemia and reperfusion. The purpose of this study to determine whether intravenous glutamine could prevent the decline of plasma glutamine level, reduce myocardial damage, improve hemodynamic profile, and reduce morbidity of on-pump CABG in patients with low ejection fraction.
Detailed description
The study was a double-blind randomized controlled trial to assess the role of glutamine as a myocardial protection during coronary artery bypass grafting under cardiopulmonary bypass in patients with left ventricle ejection fraction of 31-50%. This study was approved by Institutional Review Board of National Cardiovascular Center Harapan Kita and informed consent was obtained before randomization for patient eligible for this study. Allocation of participant to the treatment group was done by block randomization by staff who was not involved in the study. The intervention drug was prepared by pharmacist who also was not involved in the study. Glutamine solution was supplied as L-alanyl-L-glutamine dipeptide (Dipeptiven, 200 mg/mL, Fresenius Kabi, Bad Homburg, Germany) and was prepared to contain 0.5gr/kgbw glutamine diluted in NaCl 0.9% to a final volume of 500 mL. Placebo was supplied as 500 ml of NaCl 0.9%, prepared in similar fashion and packaging as glutamine solution. Principal investigator, care provider, outcome assessor, and participant were blinded to the assigned group until after the end of the study.
Baseline participant characteristics were collected before the intervention included age, sex, body weight, body height, body mass index, and documented pre-operative left ventricle ejection fraction. Coronary artery bypass grafting and cardiopulmonary bypass was done in concordance to standard operating procedure in National Cardiovascular Center Harapan Kita, followed by transit time flow meter measurement to ensure quality of the graft. Modifying factor of the study, the investigators measured duration of surgery, duration of cardiopulmonary bypass, and duration of aortic cross clamp.
The primary outcome of the study was plasma troponin I level. The investigators anticipated plasma troponin I level difference of 20% with standard deviation of 0.04 ng/mL, and for statistical power of 80% and level of significance of 0.05, the required sample size was 24.5 participants per group. As anticipation for participant drop out, the investigators planned to recruit a total of 60 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Drug: L-alanyl-L-glutamine dipeptideIntravenous L-alanyl-L-glutamine 0.5 mg/kgbw |
| Control | Placebo comparator | Drug: PlaceboIntravenous NaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with coronary heart disease indicated for elective coronary artery bypass grafting under cardiopulmonary bypass
- Patients with left ventricle ejection fraction 31% -50% confirmed by echocardiography or radio nuclear study.
- Patients age ≥18 years
- Never had heart surgery before
- Agree to participate in the study and signed informed consent
Key exclusion criteria (17 listed)
- Emergency coronary artery grafting bypass
- Having additional procedures other than coronary artery bypass grafting
- History of myocardial infarction with onset less than 3 months
- Patients with serum creatinine level more than 2 g/dL
- Patients with ALT/AST levels more than 1.5 times the upper limit of normal value
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 |
|---|---|---|
| L-alanyl-L-glutamine dipeptideAlso: DipeptivenIntravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours. | Drug | Glutamine |
| PlaceboAlso: Normal salineIntravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours. | Drug | Control |
Primary outcome
Plasma Troponin I at Baseline
Time frame: Before induction to anesthesia
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass
Time frame: 5 minute after cardiopulmonary bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass
Time frame: 6 hour after cardiopulmonary bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass
Time frame: 24 hour after cardiopulmonary bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass
Time frame: 48 hour after cardiopulmonary bypass
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Plasma Glutamine at Baseline
Time frame: Before induction to anesthesia
Plasma glutamine were measured using colorimetric tests in unit of µmol/L
Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass
Time frame: 24 hour after cardiopulmonary bypass
Plasma glutamine were measured using colorimetric tests in unit of µmol/L
15 secondary outcomes
Right Atrial Appendage Alpha-ketoglutarate
Time frame: 5 minute after cardiopulmonary bypass
Right Atrial Appendage Myocardial Injury Score
Time frame: 5 minute after cardiopulmonary bypass
Right Atrial Appendage Apoptosis Index
Time frame: 5 minute after cardiopulmonary bypass
Anti Cardiac Troponin I Expression
Time frame: 5 minute after cardiopulmonary bypass
Ejection Fraction
Time frame: Immediately after induction of anesthesia
Ejection Fraction
Time frame: 5 minutes after cardiopulmonary bypass
Cardiac Index
Time frame: Immediately after induction of anesthesia, 5 minute, 2 hour, 6 hour, 24 hour after cardiopulmonary bypass
Plasma Lactate Before Induction to Anesthesia
Time frame: Before induction to anesthesia
Plasma Lactate 5 Minute After Cardiopulmonary Bypass
Time frame: 5 minute after cardiopulmonary bypass
Plasma Lactate 6 Hours After Cardiopulmonary Bypass
Time frame: 6 hours after cardiopulmonary bypass
Plasma Lactate 24 Hours After Cardiopulmonary Bypass
Time frame: 24 hours after cardiopulmonary bypass
Plasma Lactate 48 Hours After Cardiopulmonary Bypass
Time frame: 48 hours after cardiopulmonary bypass
Intensive Care Unit Ventilation Time
Time frame: 28 days (or until hospital discharge)
Intensive Care Unit Length of Stay
Time frame: 28 days (or until hospital discharge)
Vasoactive Inotropic Score
Time frame: 28 days (or until hospital discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data reported in this study will be made available on request after publication and ending 36 months following article publication. Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.
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Coronary Artery Bypass Graft (CABG)
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.
I Made Adi Parmana principal investigator
National Cardiovascular Center Harapan Kita Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-alanyl-L-glutamine dipeptide in people with Coronary Artery Bypass and Cardiopulmonary Bypass, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
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 5 inclusion and 17 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 13 Nov 2023. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Troponin I at Baseline (time frame: Before induction to anesthesia). The study lists 7 primary outcomes in all. 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 13 Nov 2023.