NCT06295081Fut, nem toboroz
TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. nov. 18.
Rövid összefoglaló (regiszter, angolul)
The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes. The main questions it aims to answer are: Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types. Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations. Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up. This study consists of three phases: Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrations Phase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease. Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up. Participants will visit our study centre two, three or four times: Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn. Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer. Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1015 (tényleges)
- Első benyújtás
- 2024. febr. 28.
- Kezdés
- 2022. jún. 15.
- Elsődleges befejezés
- 2024. júl. 1.
- Fő szponzor
- Radboud University Medical Center
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT06295081
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 1015
- 2022. jún. 15. és az elsődleges befejezés (2024. júl. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Renal transplantation in the past
- Previous allergic reaction to iodine contrast
- Participation in other studies involving radiation
Más betegség
- Atrial fibrillation (heart rhythm disorder)
Laborértékek
- estimated glomerular filtration rate (eGFR) < 30 ml/min
Egyéb
- A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study:
- Contrast nephropathy in the past
- Not willing to be informed about potential incidental findings from the CT-scan
Kiket keres a vizsgálat
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Participant of an affiliated mass-participation exercise event with a:
- Walking distance ≥20 km
- Cycling distance ≥100 km
- Running distance ≥15 km
- Age: ≥ 40 and <70 years old
- Able to understand and perform study related procedures
- For Phase 2 of the study (i.e. assessment of (sub)clinical coronary artery disease), the following additional criteria are present:
- Free from (known) cardiovascular diseases
Életkor a regiszterben: 40 év – 70 év · Nem: nők és férfiak
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Radboudumc | Nijmegen | Hollandia | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.