Clinical trial NCT06689566: Genistein on Post-myocardial Infarction Patient With Elevated hsCRP
Official title: A Clinical Trial to Evaluate the Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients With Elevated hsCRP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myocardial Infarction (MI)
Keywords: inflammation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if genistein works to decrease inflammation in post-myocardial infarction adults. It will also learn about the safety of genistein. The main questions it aims to answer are:

Does genistein lower hsCRP in participants? What medical problems do participants have when taking genistein? Researchers will compare the baseline, under treatment and washout period hsCRP to see if genistein works to decrease inflammation.

Participants will:

Take genistein every day for 3 months with a dose-escalation manner. Afterwards, there will be 3 months washout period.

Visit the clinic once every month for checkups and tests. Keep a diary of their symptoms.

Detailed description: Background Current medical treatment for slowing the progression of atherosclerosis focus on lipid control and anti-platelet agent use. Systemic inflammation is associated with an increased risk of cardiovascular events, independent of the cholesterol level. Recent studies showed that anti-inflammatory therapy with canakinumab or colchicine led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. Genistein was reported to be associated with anti-inflammatory effects in preclinical studies. Thus, investigators hypothesized that genistein could provide a beneficial effect to show anti-inflammatory effects and slow the progression of atherosclerosis.

Method The study is a phase 2 sing-center, dose-escalation clinical trial to evaluate the benefit of genistein among stable post-MI patients receiving standard of care therapy who have been selected for an elevated inflammatory burden as determined by high sensitivity C-reactive protein (hsCRP) \> 1 mg/L

Screening will take place no earlier than 28 days after the index MI and on stable (at least 4 weeks) long term medication. Evaluations will include hsCRP and determination of cancer, tuberculosis status among other measurements and procedures and will be done at a cardiology clinic. For patients who underwent percutaneous coronary intervention (PCI) at different hospital admission than the qualifying MI; screening can be initiated no earlier than 28 days following this procedure.

Intervention Patients will be screened for suitability of genistein treatment, and the trial would be initiated after informed consent. After initiation, there will be dose-escalation every 1 month with 3 doses (250 mg, 500 mg, and 750 mg BID orally) for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.

Follow-up Laboratory data would be checked 0, 1, 3, 6 months as well as clinics follow-up. Echocardiography and 6-minute walking test will be checked at 0, 6 months. Major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, hospitalization for heart failure, or confirmed death from cardiovascular causes will be documented. Further follow-up would be arranged according to local guidelines.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Age ≥ 18 years.
3. History of spontaneous myocardial infarction at least 28 days before recruitment.
4. hsCRP ≥ 1 mg/L

Exclusion Criteria:

1. Pregnant or nursing (lactating) women
2. Women of child-bearing potential
3. Planned coronary revascularization (PCI or CABG)
4. Major non-cardiac surgical or endoscopic procedure within past 6 months
5. Symptomatic patients with Class IV heart failure (HF) (New York Heart Association \[NYHA\].
6. Uncontrolled hypertension
7. Uncontrolled diabetes
8. History or evidence of active tuberculosis (TB) infection
9. Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
10. BMI \> 40 kg/m2
11. Active cancer under treatment

Primary outcomes:
measure: Change of hsCRP
timeFrame: at 3 months
Secondary outcomes:
measure: Laboratory and functional assessment
timeFrame: at 1,3,6 months
measure: Echocardiographic assessment of ventricular function
timeFrame: at 1,3,6 months
measure: Functional assessment
timeFrame: at 1,3,6 months
Other outcomes:
measure: Safety outcome
timeFrame: At every follow-up through study completion, with an estimated average of 1 year
Locations:
Study officials:
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