An observational study in Acute Coronary Syndrome and Cardiac Ischemia, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Herlev Hospital · Observational
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
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 34 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient referred to coronary angiography due to suspicion of ischemic heart disease.
Exclusion Criteria:
10 individuals get randomised to control group.
10 individuals get randomised to a controlled coronary occlusion for 30 seconds
Other: coronary occlusion
10 individuals get randomised to a controlled coronary occlusion for 60 seconds
Other: coronary occlusion
10 individuals get randomised to a controlled coronary occlusion for 90 seconds
Other: coronary occlusion
percutaneous coronary intervention
Troponin release
Quantifying troponin T and I release after ischemic event
Time frame: 6 hours
Plan to share: No
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Herlev Hospital