Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements
ICE-land
Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia
1 other identifier
observational
34
1 country
1
Brief 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. 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
- 1.10 patients - balloon occlusion for 30 seconds
- 2.10 patients - balloon occlusion for 60 seconds
- 3.10 patients - balloon occlusion for 90 seconds
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2016
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFebruary 22, 2018
February 1, 2018
12 months
June 20, 2017
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Troponin release
Quantifying troponin T and I release after ischemic event
6 hours
Study Arms (4)
control group
10 individuals get randomised to control group.
short ischemic time
10 individuals get randomised to a controlled coronary occlusion for 30 seconds
intermediate ischemic time
10 individuals get randomised to a controlled coronary occlusion for 60 seconds
long ischemic time
10 individuals get randomised to a controlled coronary occlusion for 90 seconds
Interventions
percutaneous coronary intervention
Eligibility Criteria
Patient referred to coronary angiography due to suspicion of ischemic heart disease.
You may qualify if:
- \> 18 years of age Elective coronary angiogram Informed signed accept
You may not qualify if:
- Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin \> 100 µmol/L Heart Failure or LVEF \< 50 Severe Heart Valve Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Herlev-Gentofte Hospital
Copenhagen, 2900, Denmark
Related Publications (1)
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.
PMID: 33297742DERIVED
Biospecimen
Serum and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 29, 2017
Study Start
October 5, 2016
Primary Completion
September 30, 2017
Study Completion
October 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share