Acute Coronary SyndromeICE-landNCT03203057
Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements
An observational study of Acute Coronary Syndrome and Cardiac Ischemia, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Cardiac Ischemia
- What is being tested?
- coronary occlusion
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2016to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient referred to coronary angiography due to suspicion of ischemic heart disease.
Who may be able to join
- > 18 years of age Elective coronary angiogram Informed signed accept
Who cannot join
- Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin > 100 µmol/L Heart Failure or LVEF < 50 Severe Heart Valve Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia
Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea.
Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending on the assay. High-sensitivity assays measure concentrations that are ten-times lower than earlier generations of assays. However, the time from when troponin is elevated in the bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully known.
Read more
During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to do a short, controlled occlusion of coronary artery by inflating a small balloon in one of the coronary arteries. Numerous earlier studies in patients have used this method for induced occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured troponin I.
The aim with this study is to quantify and compare the release of troponin T and troponin I in the early hours after a controlled induced ischemia.
Study Design This is a prospective, descriptive and experimental study. There will be included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4 groups.
0: 10 patients - control group, no balloon occlusion
- 10 patients - balloon occlusion for 30 seconds
- 10 patients - balloon occlusion for 60 seconds
- 10 patients - balloon occlusion for 90 seconds
Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6 hours: Every 30 minutes
Statistics This is a pilot study and it is estimated that ten patients are sufficient number of patients in each group to assess elevation of troponin after occlusion of coronary artery. The thesis is there is a dosage-response correlation between the length of balloon occlusion and the concentration of troponin in blood stream.
- Conditions
- Acute Coronary Syndrome, Cardiac Ischemia
- Being tested
- coronary occlusion
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary occlusionOther
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| control group | 10 individuals get randomised to control group. | |
| short ischemic time | 10 individuals get randomised to a controlled coronary occlusion for 30 seconds Receives: Other: coronary occlusion | |
| intermediate ischemic time | 10 individuals get randomised to a controlled coronary occlusion for 60 seconds Receives: Other: coronary occlusion | |
| long ischemic time | 10 individuals get randomised to a controlled coronary occlusion for 90 seconds Receives: Other: coronary occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin release
Quantifying troponin T and I release after ischemic event
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start5 Oct 2016
- Primary completion30 Sep 2017
- Study completion1 Oct 2017
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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asthildur Arnadottir, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203057
- Sponsor's protocol ID
- H-16027749
- Acronym
- ICE-land
- Status last verified
- Feb 2018
- First submitted
- 20 Jun 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnadottir A, Pedersen S, Bo Hasselbalch R, Goetze JP, Friis-Hansen LJ, Bloch-Munster AM, Skov Jensen J, Bundgaard H, Iversen K. Temporal Release of High-Sensitivity Cardiac Troponin T and I and Copeptin After Brief Induced Coronary Artery Balloon Occlusion in Humans. Circulation. 2021 Mar 16;143(11):1095-1104. doi: 10.1161/CIRCULATIONAHA.120.046574. Epub 2020 Dec 10.
PubMed 33297742
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia
- ClinicalTrials.gov ID
- NCT03203057
- Acronym / sponsor ID
- ICE-land / H-16027749
- Conditions
- Acute Coronary Syndrome, Cardiac Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 29 Jun 2017 (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.
Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea.
Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending on the assay. High-sensitivity assays measure concentrations that are ten-times lower than earlier generations of assays. However, the time from when troponin is elevated in the bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully known.
During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to do a short, controlled occlusion of coronary artery by inflating a small balloon in one of the coronary arteries. Numerous earlier studies in patients have used this method for induced occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured troponin I.
The aim with this study is to quantify and compare the release of troponin T and troponin I in the early hours after a controlled induced ischemia.
Study Design This is a prospective, descriptive and experimental study. There will be included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4 groups.
0: 10 patients - control group, no balloon occlusion
- 10 patients - balloon occlusion for 30 seconds
- 10 patients - balloon occlusion for 60 seconds
- 10 patients - balloon occlusion for 90 seconds
Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6 hours: Every 30 minutes
Statistics This is a pilot study and it is estimated that ten patients are sufficient number of patients in each group to assess elevation of troponin after occlusion of coronary artery. The thesis is there is a dosage-response correlation between the length of balloon occlusion and the concentration of troponin in blood stream.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | –10 individuals get randomised to control group. |
| short ischemic time | – | Other: coronary occlusion10 individuals get randomised to a controlled coronary occlusion for 30 seconds |
| intermediate ischemic time | – | Other: coronary occlusion10 individuals get randomised to a controlled coronary occlusion for 60 seconds |
| long ischemic time | – | Other: coronary occlusion10 individuals get randomised to a controlled coronary occlusion for 90 seconds |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient referred to coronary angiography due to suspicion of ischemic heart disease.
Key inclusion criteria (1 listed)
- > 18 years of age Elective coronary angiogram Informed signed accept
Key exclusion criteria (1 listed)
- Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin > 100 µmol/L Heart Failure or LVEF < 50 Severe Heart Valve Disease
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 |
|---|---|---|
| coronary occlusionpercutaneous coronary intervention | Other | intermediate ischemic time, long ischemic time, short ischemic time |
Primary outcome
Troponin release
Time frame: 6 hours
Quantifying troponin T and I release after ischemic event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 33297742Arnadottir A, Pedersen S, Bo Hasselbalch R, Goetze JP, Friis-Hansen LJ, Bloch-Munster AM, Skov Jensen J, Bundgaard H, Iversen K. Temporal Release of High-Sensitivity Cardiac Troponin T and I and Copeptin After Brief Induced Coronary Artery Balloon Occlusion in Humans. Circulation. 2021 Mar 16;143(11):1095-1104. doi: 10.1161/CIRCULATIONAHA.120.046574. Epub 2020 Dec 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Coronary Syndrome and Cardiac Ischemia, run by Herlev Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Feb 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Troponin release (time frame: 6 hours). 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 NCT03203057, 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 22 Feb 2018.