Table 3.
Planned outcomes of the IHD-EPITRAN study. Outcome 1 and outcomes 2–5 encase inter- and intra-cohort comparisons, respectively. Morbidity parameters: Section 2.3.2. A-to-I, adenosine-to-inosine; AVR, aortic valve replacement (III); AVS, aortic valve stenosis; CABG, coronary artery bypass grafting (II); CCTA, coronary computed tomography angiogram (IV); m6A, N6-methyladenosine; IR, ischemia-reperfusion; PCI, percutaneous coronary intervention; STEMI, ST-elevation MI (I).
| Primary | Secondary |
|---|---|
| 1. Study sample m6A and A-to-I profiles from the recruitment stage associating with IHD and AVS pathophysiology 1.1. Acute IR controlled for stable ishcemia, pressure overload, and homeostasis (I vs. II-III-IV) 1.2. Stable ishcemia controlled for acute IR, pressure overload, and homeostasis (II vs. I-III-IV) 1.3. Acute IR controlled for homeostasis (I vs. IV) 1.4. Pressure overload controlled for acute IR, stable ishcemia, and hemeostasis (III vs. I-II-IV) |
4. Changes in the study sample m6A and A-to-I profiles (Recruitment vs. 3-months) associating to 4.1 Therapy effects on Pathophysiology at 3-month follow-up 4.1.1. STEMI-PCI effects (Resolution and relievement acute IR, remodelingl I vs. I) 4.1.2. IHD-CABG effects (Relievement of stable ischemia, remodeling; II vs III) 4.1.3. AVS-AVR effects (Relievement of pressure overload, remodeling; III vs. III) 4.2 All-cause mortality during 3-month follow-up 4.3 Beneficial/adverse/no-response for therapy as measured via echocardiography at 3 months 4.4 Surrogate (non-)metabolite CVD biomarker levels at recruitment, 3 months, changes between |
| 2. Study sample m6A and A-to-I profiles from the recruitment stage associating with 3-moth follow-up clinicial parmeters 2.1. Cardiovascular mortality 2.2 Cardiovascular morbidity 2.3. MACCE 2.4 Cardiovascular medication increases or reductions |
5. study sample m6A and A-to-I profiles from the recruitment stage as in outcomes 4.2.–4.5. |
| 3. Changes in the sample m6A and A-to-I profiles (recruitment vs. 3-months) as in outcome 2 | 6. Study sample quantitative alterations in other RNA modifications as in outcomes 1–5 (2.3.8.) |
| 7. Plasma metabolute and non-metabolite CVD biomarkers as in outcomes 1–5 (excl.4.4) (2.3.5.) | |
| 8. Biobank plasma and RAA sample proteomic profiles as in outcomes 1–5 (2.3.10.) | |
| 9. Whole blood sample transcriptome-based leukpcyte profiles as in outcomes 1–5 |