Coronary Artery DiseaseTREATNCT06295081
TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
An observational study of Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise exposure
- How many people
- 1,015 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jun 2022to 1 Jul 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
Study population: 1500 Athletes will be recruited at mass-participation long-distance exercise events and stratified for type of sport (e.g. walking, cycling, running). Recruitment will take place via official websites/newsletters of the associated exercise events and social media channels. Our research has extensive experience performing studies in mass-participation exercise events, such as the Four Days Marches, Seven Hills Run, Eindhoven Marathon, Amsterdam Marathon, Maastricht Marathon in which we successfully included hundreds of participants. Therefore, we expect no difficulty to reach our target number of included participants.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study:
- Renal transplantation in the past
- Contrast nephropathy in the past
- estimated glomerular filtration rate (eGFR) < 30 ml/min
- Atrial fibrillation (heart rhythm disorder)
- Previous allergic reaction to iodine contrast
- Participation in other studies involving radiation
- Not willing to be informed about potential incidental findings from the CT-scan
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed description
For a detailed description, please see the attached study protocol under 'Documents'.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise exposure
- Keywords
- coronary artery disease, exercise, athlete, troponin, radiology, biomarker
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise exposureOther
Exercise is NOT part of our study protocol. Participants will voluntarily participate in a mass-participation exercise event (i.e. walking, cycling or running). Participation in this exercise event is voluntary and independent from participation in this study (i.e. participants would also take part in the exercise event if they did not participate in our study). Therefore, we do not consider the performed exercise an intervention or part of our study protocol. Hence, we consider our study design to be observational.
Participants will perform exercise during a mass-participation exercise event, stratified for type of exercise (walking versus running versus cycling; n=500 each).
The mass-participation exercise events have a sport-specific minimum distance of:
a mass-participation exercise event with a:
- Walking distance ≥20 km
- Cycling distance ≥100 km
- Running distance ≥15 km
| Study group | Role | What they receive |
|---|---|---|
| Walkers | Amateur athletes who perform a walking exercise with a minimum distance of 20 km Receives: Other: Exercise exposure | |
| Runners | Amateur athletes who perform a running exercise with a minimum distance of 15 km Receives: Other: Exercise exposure | |
| Cyclists | Amateur athletes who perform a cycling exercise with a minimum distance of 100 km Receives: Other: Exercise exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity cardiac troponin I (hs-cTnI)
Concentrations of high-sensitivity cardiac troponin I (hs-cTnI) in plasma in ng/L
Measured: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
High-sensitivity cardiac troponin T (hs-cTnT)
Concentrations of high-sensitivity cardiac troponin T (hs-cTnT) in plasma in ng/L
Measured: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
Secondary outcomes (6)
General CT scan data
CT scan date (dd-mm-yyyy); average heart rate during scan (bpm); total radiation dose (mSv); beta-blockers administration (yes/no, if yes: dose (mg)); nitro-glycerine administration (yes/no, if yes: dose (mg)); image quality (good/moderate/poor); FFR series obtained (yes/no, if yes: quality(good/moderate/poor)); incidental findings.
Measured: within 3 months after inclusion
Coronary artery calcification score
Coronary artery calcium score [=CACS], per coronary artery or other (LM/LAD/LCX/RCA/RI/Aorta/Valves/Other) and total: lesion count (n); Agatston score (AU); volume (mm3); density (HU). Total CACS (AU); total volume (mm3); total density (HU); MESA percentile (%).
LM: left main; LAD: left anterior descending; LCX: left circumflex; RCA: right coronary artery; RI: ramus intermedius; AU: Agatston units; HU: Hounsfield units; MESA: Multi-Ethnic Study of Atherosclerosis.
Measured: within 3 months after inclusion
Coronary stenosis and plaque characteristics
Coronary stenoses, per segment (1-18): maximum stenosis degree (0%/1-24%/25-49%/50-69%/70-99%/100%/non-diagnostic/vessel absent); number of calcified plaques (n); number of partially calcified plaques (n); number of non-calcified plaques (n).
Presence of myocardial bridging (yes/no); heart 'dominance' (PDA supplied by RCA/PDA supplied by LCX); room for general comments on CT scan.
In general, not per segment: stenosis involvement score (n); stenosis severity score (n); plaque burden (P0/P1/P2/P3/P4); high-risk plaque features, per type [low attenuation plaque/positive remodelling/spotty calcification/napkin ring sign] (yes/no); modifiers, per modifier [non-diagnostic/having ≥high-risk plaque features/ischemia/exceptions including coronary artery dissection, anomalous origin of the coronary arteries, coronary artery (pseudo) aneurysm, vasculitis, coronary artery fistula, extrinsic coronary artery compression, arterio-venous malformation, other causes] (yes/no); CAD-RADS 2.0 score.
Measured: within 3 months after inclusion
Computed tomography derived Fractional Flow Reserve
CT-derived FFR per coronary artery (LM/LAD/LCX/RCA): FFR at the beginning of vessel (ratio); FFR at 1.5 mm diameter of vessel or most distal evaluable part (ratio); FFR at 20 mm distal from stenosis (ratio).
FFR signs for ischemia present [=FFR≤0.75] (yes/no); borderline ischemia [=FFR 0.76-0.80] (yes/no), non-ischemia [=FFR >0.80] (yes/no).
FFR: fractional flow reserve
Measured: within 3 months after inclusion
Incidence of mortality
Incidence of mortality (yes/no), if yes: date of death (dd-mm-yyyy) and cause of death; cardiovascular death (yes/no).
Measured: 5 years after inclusion, 10 years after inclusion, 15 years after inclusion, 20 years after inclusion. Time-to-event: From the date of inclusion until the date of first documented date of death (from any cause), assessed up to 20 years after inclusion
Incidence of major adverse cardiovascular events
Incidence of MACE (yes/no), if yes: date, type of event (myocardial infarction/stroke/heart failure/revascularisation (both acute and elective)/sudden cardiac arrest), hospitalization (yes/no).
MACE: major adverse cardiovascular events.
Measured: At 1/2/3/4/5/6/7/8/9/10/11/12/13/14/15/16/17/18/19/20 years after inclusion.Time-to-event: From the date of inclusion until the date of first documented major adverse cardiovascular event, assessed up to 20 years after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Jun 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Thijs Eijsvogels, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295081
- Sponsor's protocol ID
- NL79864.091.22
- Other IDs
- 112927
- Acronym
- TREAT
- Status last verified
- Jan 2024
- First submitted
- 28 Feb 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be stored in the myDRE research environment platform (myDRE, anDREa BV (Digital Research Environment), Nijmegen, the Netherlands) for at least 20 years in a safe way adhering to the General Data Protection Regulation, Good Clinical Practice and Good Laboratory Practice guidelines. We will use standard software packages for data handling and statistical analyses (e.g. Castor EDC, SPSS, Microsoft Excel). In line with open science and the FAIR principles (Findable, Accessible, Interoperable and Reusable), data from the TREAT study will be made available for reuse upon reasonable request via the corresponding author.
Publications
Janssen SLJE, Lamers SK, Vroemen WHM, Denessen EJS, Berge K, Bekers O, Hopman MTE, Brink M, Habets J, Nijveldt R, Van Everdingen WM, Aengevaeren VL, Mingels AMA, Eijsvogels TMH. Cardiac troponin concentrations following exercise and the association with cardiovascular disease and outcomes: rationale and design of the prospective TREAT cohort study. BMJ Open Sport Exerc Med. 2024 Jun 13;10(2):e002070. doi: 10.1136/bmjsem-2024-002070. eCollection 2024.
PubMed 38882206
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
- ClinicalTrials.gov ID
- NCT06295081
- Acronym / sponsor ID
- TREAT / NL79864.091.22
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, exercise, athlete, troponin, radiology, biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2044 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For a detailed description, please see the attached study protocol under 'Documents'.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walkers | – | Other: Exercise exposureAmateur athletes who perform a walking exercise with a minimum distance of 20 km |
| Runners | – | Other: Exercise exposureAmateur athletes who perform a running exercise with a minimum distance of 15 km |
| Cyclists | – | Other: Exercise exposureAmateur athletes who perform a cycling exercise with a minimum distance of 100 km |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1500 Athletes will be recruited at mass-participation long-distance exercise events and stratified for type of sport (e.g. walking, cycling, running). Recruitment will take place via official websites/newsletters of the associated exercise events and social media channels. Our research has extensive experience performing studies in mass-participation exercise events, such as the Four Days Marches, Seven Hills Run, Eindhoven Marathon, Amsterdam Marathon, Maastricht Marathon in which we successfully included hundreds of participants. Therefore, we expect no difficulty to reach our target number of included participants.
Key inclusion criteria (9 listed)
- 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:
- 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:
Key exclusion criteria (8 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study:
- Renal transplantation in the past
- Contrast nephropathy in the past
- estimated glomerular filtration rate (eGFR) < 30 ml/min
- Atrial fibrillation (heart rhythm disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise exposureExercise is NOT part of our study protocol. Participants will voluntarily participate in a mass-participation exercise event (i.e. walking, cycling or running). Participation in this exercise event is voluntary and independent from participation in this study (i.e. participants would also take part in the exercise event if they did not participate in our study). Therefore, we do not consider the performed exercise an intervention or part of our study protocol. Hence, we consider our study design to be observational. Participants will perform exercise during a mass-participation exercise event, stratified for type of exercise (walking versus running versus cycling; n=500 each). The mass-participation exercise events have a sport-specific minimum distance of: a mass-participation exercise event with a: * Walking distance ≥20 km * Cycling distance ≥100 km * Running distance ≥15 km | Other | Cyclists, Runners, Walkers |
Primary outcome
High-sensitivity cardiac troponin I (hs-cTnI)
Time frame: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
Concentrations of high-sensitivity cardiac troponin I (hs-cTnI) in plasma in ng/L
High-sensitivity cardiac troponin T (hs-cTnT)
Time frame: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
Concentrations of high-sensitivity cardiac troponin T (hs-cTnT) in plasma in ng/L
6 secondary outcomes
General CT scan data
Time frame: within 3 months after inclusion
Coronary artery calcification score
Time frame: within 3 months after inclusion
Coronary stenosis and plaque characteristics
Time frame: within 3 months after inclusion
Computed tomography derived Fractional Flow Reserve
Time frame: within 3 months after inclusion
Incidence of mortality
Time frame: 5 years after inclusion, 10 years after inclusion, 15 years after inclusion, 20 years after inclusion. Time-to-event: From the date of inclusion until the date of first documented date of death (from any cause), assessed up to 20 years after inclusion
Incidence of major adverse cardiovascular events
Time frame: At 1/2/3/4/5/6/7/8/9/10/11/12/13/14/15/16/17/18/19/20 years after inclusion.Time-to-event: From the date of inclusion until the date of first documented major adverse cardiovascular event, assessed up to 20 years after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 38882206Janssen SLJE, Lamers SK, Vroemen WHM, Denessen EJS, Berge K, Bekers O, Hopman MTE, Brink M, Habets J, Nijveldt R, Van Everdingen WM, Aengevaeren VL, Mingels AMA, Eijsvogels TMH. Cardiac troponin concentrations following exercise and the association with cardiovascular disease and outcomes: rationale and design of the prospective TREAT cohort study. BMJ Open Sport Exerc Med. 2024 Jun 13;10(2):e002070. doi: 10.1136/bmjsem-2024-002070. eCollection 2024.
- Individual participant dataSharing planned: Yes. All data will be stored in the myDRE research environment platform (myDRE, anDREa BV (Digital Research Environment), Nijmegen, the Netherlands) for at least 20 years in a safe way adhering to the General Data Protection Regulation, Good Clinical Practice and Good Laboratory Practice guidelines. We will use standard software packages for data handling and statistical analyses (e.g. Castor EDC, SPSS, Microsoft Excel). In line with open science and the FAIR principles (Findable, Accessible, Interoperable and Reusable), data from the TREAT study will be made available for reuse upon reasonable request via the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thijs Eijsvogels, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-sensitivity cardiac troponin I (hs-cTnI) (time frame: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.