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Effect of melatonin versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty

Effect of melatonin versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty: a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120215009014N539
Enrollment
150
Registered
2024-11-14
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary angioplasty. Angioplasty status

Interventions

Intervention 1: Intervention group: Routine treatment measures plus melatonin injection of 20 mg as a single dose immediately before angioplasty, then melatonin injection of 10 mg for 3 days. Interven

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18 to 70 years Primary angioplasty candidate Symptoms of cardiac ischemia persist for at least 30 minutes Less than 12 hours have passed since the onset of myocardial infarction symptoms ST segment elevation in electrocardiogram

Exclusion criteria

Exclusion criteria: Consumption of antioxidant compounds in the last month Taking other drugs with nephrotoxic effects Candidate patients for thrombolytic therapy Cardiogenic shock Advanced liver failure Heart failure Autoimmune diseases

Design outcomes

Primary

MeasureTime frame
Plasma creatinine level. Timepoint: Before intervention and at 24, 48 and 72 hours later. Method of measurement: By blood sampling.;BUN plasma level. Timepoint: Before intervention and at 24, 48 and 72 hours later. Method of measurement: By blood sampling.;Plasma level of eGFR. Timepoint: Before intervention and at 24, 48 and 72 hours later. Method of measurement: By blood sampling.

Secondary

MeasureTime frame
Plasma level of lipid peroxidation, superoxide dismutase and glutathione peroxidase. Timepoint: Before the intervention and 72 hours later. Method of measurement: By blood sampling.;Plasma level of CRP. Timepoint: Before the intervention and 72 hours later. Method of measurement: By blood sampling.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azadeh Eshraghi

Iran University of Medical Sciences

aepharm@gmail.com+98 21 8670 2503

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026