Blood biomarkers for coronary artery disease
Epitranscriptomic Biomarkers for Ischemic Heart Disease (IHD-EPITRAN) - A Prospective Cohort Study
This study is testing if certain blood markers can help doctors better diagnose and treat people with ischemic heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital District of Helsinki and Uusimaa Academic / other |
| Locations | 1 site (Helsinki, Uusimaa) |
| Trial ID | NCT04533282 on ClinicalTrials.gov |
What this trial studies
This study aims to identify epitranscriptomic blood biomarkers associated with ischemic heart disease (IHD) to improve early diagnosis and treatment efficacy. It involves collecting blood samples and right atrial appendage tissue samples from patients with various forms of IHD, including those undergoing procedures like PCI and CABG. The study will analyze these samples alongside clinical assessments and echocardiography to uncover potential biomarkers that could indicate disease progression and severity.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed ischemic heart disease, such as those experiencing STEMI or undergoing elective surgeries for chronic IHD.
Not a fit: Patients with non-ischemic heart conditions or those who do not meet the specific inclusion criteria for the cohorts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new blood biomarkers that enable earlier diagnosis and better management of ischemic heart disease.
How similar studies have performed: While the approach of using epitranscriptomics is relatively novel, similar studies have shown promise in identifying biomarkers for other diseases, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Cohort I, STEMI + PCI:
1. Earlier PCIs and silent infarctions eligible.
2. ECG confirmed STEMI with Troponin I elevation and pressing chest pain.
3. ECG-indicated local damage correlates with recorded dyskinesia in TTE.
4. During acute PCI and angiography, only one clear occlusion.
5. Successful initial coronary artery reperfusion during PCI.
2. Cohort II, Chronic IHD + elective CABG:
1. Chronic and either CCS or NYHA II-IV symptoms for at least one month.
2. First and elective operation. Only heart operation to be performed.
3. In transthoracic echocardiogram (TTE):
* No indication of cardiomyopathy other than ischemic.
* No pathological remodelling (valves, ventricles and atrias).
* No clear indication of significant heart failure (i.e. LVEF \> 25%)
3. Cohort III, elective aortic replacement therapy (AVR) for stenosis:
1. Chronic and either CCS or NYHA II-IV symptoms for at least one month.
2. Operated as an open heart surgery (either prosthetic or biovalves)
3. No signs of IHD in coronary angiography.
4. Both bicuspid and tricuspid valves eligible.
4. Cohort IV, IHD-negative healthy controls defined by coronary CT:
1. Computerized tomography angiogram results are categorized as negative for coronary artery disease.
2. No known heart disease.
Exclusion Criteria:
* Condition that limits life expectancy.
* Combination procedures (i.e. CABG+valve).
* Chronic renal insufficiency (KDIGO scale Pt-GFR \< 45/min).
* Active inflammatory/infectious process.
* Known disease affecting either blood or bone marrow.
* Structural or functional congenital heart disease.
* Recorded atrial fibrillation.
* Other comorbidities in poor clinical control (i.e. uncontrolled severe hypertension \>170-180/100 and for diabetes HbA1c \> 60 mmol/l).
* Insulin treated diabetes.
Where this trial is running
Helsinki, Uusimaa
- Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit — Helsinki, Uusimaa, Finland (Recruiting)
Study contacts
- Principal investigator: Esko Kankuri, Docent — University of Helsinki, Faculty of Medicine, Department of Pharmacology
- Study coordinator: Antti E Vento, Docent
- Email: antti.vento@hus.fi
- Phone: 09 471 72200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.