Reperfusion Injury, MyocardialNCT03303378
Effects of Melatonin on Reperfusion Injury
A study testing melatonin (Helsinn Chemical Co, Biasca, Switzerland) in people with Reperfusion Injury, Myocardial, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Reperfusion Injury, Myocardial
- What is being tested?
- melatonin (Helsinn Chemical Co, Biasca, Switzerland)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Nov 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention
Who cannot join
- unconscious at presentation
- had cardiogenic shock
- had a history of myocardial infarction
- stent thrombosis
- renal insufficiency
- had previously undergone coronary artery bypass surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA General Hospital
Beijing, Beijing Municipality, 100853
Wei Ren Chen, M.D., +8610-66939709, chen_weiren@sina.com
Yun Dai Chen, M.D.
About this study
Official title: Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.
- Conditions
- Reperfusion Injury, Myocardial
- Being tested
- melatonin (Helsinn Chemical Co, Biasca, Switzerland), Placebos
- Keywords
- melatonin, Reperfusion Injury, myocardial infarction
- Medical subject headings
- Myocardial Reperfusion Injury, Reperfusion Injury, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin (Helsinn Chemical Co, Biasca, Switzerland)Drug
Also called melatonin
Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min.
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).
PlacebosDrug
Also called Placebo
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg). Receives: Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland) |
| Control group | Placebo comparator | Patients will receive the same dose of placebo. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The salvage index
The salvage index measured by cardiac magnetic resonance
Measured: 3 months after primary percutaneous coronary intervention
Secondary outcomes (3)
The final infarct size
The final infarct size measured by cardiac magnetic resonance
Measured: 3 months after primary percutaneous coronary intervention
major adverse cardiovascular events (MACE)
recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.
Measured: 3 months after primary percutaneous coronary intervention
treatment-emergent adverse events (TEAEs)
hypoglycemia, nausea
Measured: 3 months after primary percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reperfusion Injury, MyocardialStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Wei Ren, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303378
- Sponsor's protocol ID
- MelonRI
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominguez-Rodriguez A, Abreu-Gonzalez P, de la Torre-Hernandez JM, Consuegra-Sanchez L, Piccolo R, Gonzalez-Gonzalez J, Garcia-Camarero T, Del Mar Garcia-Saiz M, Aldea-Perona A, Reiter RJ; MARIA Investigators. Usefulness of Early Treatment With Melatonin to Reduce Infarct Size in Patients With ST-Segment Elevation Myocardial Infarction Receiving Percutaneous Coronary Intervention (From the Melatonin Adjunct in the Acute Myocardial Infarction Treated With Angioplasty Trial). Am J Cardiol. 2017 Aug 15;120(4):522-526. doi: 10.1016/j.amjcard.2017.05.018. Epub 2017 May 30.
PubMed 28645475Zhou H, Zhang Y, Hu S, Shi C, Zhu P, Ma Q, Jin Q, Cao F, Tian F, Chen Y. Melatonin protects cardiac microvasculature against ischemia/reperfusion injury via suppression of mitochondrial fission-VDAC1-HK2-mPTP-mitophagy axis. J Pineal Res. 2017 Aug;63(1):e12413. doi: 10.1111/jpi.12413. Epub 2017 Apr 27.
PubMed 28398674Dominguez-Rodriguez A, Abreu-Gonzalez P, Garcia-Gonzalez MJ, Kaski JC, Reiter RJ, Jimenez-Sosa A. A unicenter, randomized, double-blind, parallel-group, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty The Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty (MARIA) trial: study design and rationale. Contemp Clin Trials. 2007 Jul;28(4):532-9. doi: 10.1016/j.cct.2006.10.007. Epub 2006 Oct 17.
PubMed 17123867
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03303378
- Acronym / sponsor ID
- MelonRI
- Conditions
- Reperfusion Injury, Myocardial
- Keywords
- melatonin, Reperfusion Injury, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 6 Oct 2017 (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.
Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg). |
| Control group | Placebo comparator | Drug: PlacebosPatients will receive the same dose of placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention
Key exclusion criteria (6 listed)
- unconscious at presentation
- had cardiogenic shock
- had a history of myocardial infarction
- stent thrombosis
- renal insufficiency
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 |
|---|---|---|
| melatonin (Helsinn Chemical Co, Biasca, Switzerland)Also: melatoninPatients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min. The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention). | Drug | Melatonin group |
| PlacebosAlso: PlaceboThe temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention). | Drug | Control group |
Primary outcome
The salvage index
Time frame: 3 months after primary percutaneous coronary intervention
The salvage index measured by cardiac magnetic resonance
3 secondary outcomes
The final infarct size
Time frame: 3 months after primary percutaneous coronary intervention
major adverse cardiovascular events (MACE)
Time frame: 3 months after primary percutaneous coronary intervention
treatment-emergent adverse events (TEAEs)
Time frame: 3 months after primary percutaneous coronary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Results publication: PubMed 28645475Dominguez-Rodriguez A, Abreu-Gonzalez P, de la Torre-Hernandez JM, Consuegra-Sanchez L, Piccolo R, Gonzalez-Gonzalez J, Garcia-Camarero T, Del Mar Garcia-Saiz M, Aldea-Perona A, Reiter RJ; MARIA Investigators. Usefulness of Early Treatment With Melatonin to Reduce Infarct Size in Patients With ST-Segment Elevation Myocardial Infarction Receiving Percutaneous Coronary Intervention (From the Melatonin Adjunct in the Acute Myocardial Infarction Treated With Angioplasty Trial). Am J Cardiol. 2017 Aug 15;120(4):522-526. doi: 10.1016/j.amjcard.2017.05.018. Epub 2017 May 30.
- Results publication: PubMed 28398674Zhou H, Zhang Y, Hu S, Shi C, Zhu P, Ma Q, Jin Q, Cao F, Tian F, Chen Y. Melatonin protects cardiac microvasculature against ischemia/reperfusion injury via suppression of mitochondrial fission-VDAC1-HK2-mPTP-mitophagy axis. J Pineal Res. 2017 Aug;63(1):e12413. doi: 10.1111/jpi.12413. Epub 2017 Apr 27.
- Results publication: PubMed 17123867Dominguez-Rodriguez A, Abreu-Gonzalez P, Garcia-Gonzalez MJ, Kaski JC, Reiter RJ, Jimenez-Sosa A. A unicenter, randomized, double-blind, parallel-group, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty The Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty (MARIA) trial: study design and rationale. Contemp Clin Trials. 2007 Jul;28(4):532-9. doi: 10.1016/j.cct.2006.10.007. Epub 2006 Oct 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin (Helsinn Chemical Co, Biasca, Switzerland) in people with Reperfusion Injury, Myocardial, run by Chinese PLA General Hospital at 1 site in China.
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 6 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 6 Oct 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 China. 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.
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 wei ren chen, M.D. (+8610-66876231, chen_weiren@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The salvage index (time frame: 3 months after primary percutaneous coronary intervention). 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 NCT03303378, which also lists 3 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 6 Oct 2017.