ClinicalTrials.gg
Sign In
Status unknownNCT03303378Updated Oct 6, 2017

Effects of Melatonin on Reperfusion Injury

An interventional study of melatonin (Helsinn Chemical Co, Biasca, Switzerland) and Placebos in Reperfusion Injury, Myocardial, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Reperfusion Injury, Myocardial

Keywords

  • melatonin
  • Reperfusion Injury
  • myocardial infarction
03

In context

Myocardial Reperfusion Injury

57 studies on the registry are indexed under Myocardial Reperfusion Injury; 6 are open to participants now.

This study's planned enrollment of 190 is above the median of 81 across 46 interventional studies indexed under Myocardial Reperfusion Injury.

Browse Myocardial Reperfusion Injury studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.

Browse Chinese PLA General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention

Exclusion criteria

Exclusion Criteria:

  • unconscious at presentation
  • had cardiogenic shock
  • had a history of myocardial infarction
  • stent thrombosis
  • renal insufficiency
  • had previously undergone coronary artery bypass surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    Melatonin group

    Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).

    Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)

  • Placebo comparator
    Control group

    Patients will receive the same dose of placebo.

    Drug: Placebos

Interventions

  • Drugmelatonin (Helsinn Chemical Co, Biasca, Switzerland)

    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).

    Also known as: melatonin

  • DrugPlacebos

    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).

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. The salvage index

    The salvage index measured by cardiac magnetic resonance

    Time frame: 3 months after primary percutaneous coronary intervention

Secondary outcomes

  1. The final infarct size

    The final infarct size measured by cardiac magnetic resonance

    Time frame: 3 months after primary percutaneous coronary intervention

  2. major adverse cardiovascular events (MACE)

    recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.

    Time frame: 3 months after primary percutaneous coronary intervention

  3. treatment-emergent adverse events (TEAEs)

    hypoglycemia, nausea

    Time frame: 3 months after primary percutaneous coronary intervention

07

Study locations

1 of 1 sites recruiting
  • PLA General Hospital
    Beijing, Beijing 100853, China
    Recruiting
    • Wei Ren Chen, M.D. · Contactchen_weiren@sina.com · +8610-66939709
    • Yun Dai Chen, M.D. · Principal investigator
08

References and documents

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 28645475 ↗
  • Zhou 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 28398674 ↗
  • Dominguez-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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Nov 2019, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Oct 6, 2017
StartEst.
Nov 1, 2017
Primary completionEst.
Nov 1, 2019
CompletionEst.
Nov 1, 2019
Last update
Oct 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03303378
Lead sponsor
Chinese PLA General Hospital
Responsible party
Chen Wei Ren, MD (doctor, Chinese PLA General Hospital) — Principal investigator
First posted
Oct 6, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Nov 1, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Oct 6, 2017

Study contacts

wei ren chen, M.D.
Contact
chen_weiren@sina.com
+8610-66876231

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Melatonin

Other studies in this condition

Myocardial Reperfusion Injury →

Other studies from this sponsor

Chinese PLA General Hospital →

Start the discussion