Herlev-Gentofte Hospital
Copenhagen, 2900, Denmark
NCT Number: NCT03203057
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
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Observational
Copenhagen, 2900, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
percutaneous coronary intervention
Time frame: 6 hours
Quantifying troponin T and I release after ischemic event
Herlev Hospital
Other
Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia
Acronym: ICE-land
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04458155
Acute Coronary Syndrome, Arterial Occlusive Diseases
Venlo, Limburg, Netherlands
View Trial DetailsNCT03419325
Acute Coronary Syndrome, Arterial Occlusive Diseases
Carolina, Puerto Rico
View Trial DetailsNCT05514938
Acute Coronary Syndrome, Arterial Occlusive Diseases
Dallas, Texas, United States
View Trial DetailsNCT05726019
Acute Coronary Syndrome, Arterial Occlusive Diseases
São Paulo, Brazil
View Trial Details