Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial
Indonesia50 participantsStarted 2025-02-05
Plain-language summary
This study aims to evaluate whether supplementation with a combination of curcumin and piperine can help reduce inflammation and oxidative stress in patients who have experienced a heart attack called ST-Elevation Myocardial Infarction (STEMI) and are undergoing a procedure known as primary percutaneous coronary intervention (PPCI).
Curcumin, a natural compound from turmeric, is known for its antioxidant and anti-inflammatory effects, but it is not easily absorbed by the body. Piperine, a compound from black pepper, can improve curcumin absorption. By combining the two, we hope to maximize their potential benefits.
The study will measure markers of inflammation (high-sensitivity C-reactive protein, hsCRP) and oxidative stress (malondialdehyde, MDA) at three time points: before treatment, shortly after the PPCI procedure, and after 28 days of supplementation.
The main question is whether curcumin-piperine supplementation can provide additional protection against inflammation and oxidative stress compared to a placebo, potentially supporting recovery and reducing the risk of future heart problems.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 80 years.
* Confirmed diagnosis of ST-Elevation Myocardial Infarction (STEMI). Symptom onset within 12 hours, or within 12 to 72 hours in cases with an indication for primary percutaneous coronary intervention (PPCI).
* Receiving standard-of-care medical therapy according to current guidelines, including:
Dual antiplatelet therapy. Angiotensin-Converting Enzyme Inhibitors (ACE-i) or Angiotensin Receptor Blockers (ARBs).
Statins. Beta-blockers.
Exclusion Criteria:
* Regular prior use of curcumin supplementation.
* Hemodynamic instability or severe dyspnoea with clinical signs of congestion (elevated jugular venous pressure, pulmonary rales affecting \>1/3 of lung fields, hepatomegaly, ascites, or peripheral oedema).
* History of prior myocardial infarction, previous percutaneous coronary intervention, or coronary artery bypass graft surgery.
* Known hypersensitivity to curcumin or piperine.
* Active malignancy.
* Chronic infections (e.g., hepatitis, tuberculosis, or HIV).
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or rapidly declining renal function.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28
Timeframe: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention
2
Change from Baseline in Malondialdehyde (MDA) at Day 28
Timeframe: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention