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Clinical Trials/NCT03203057
NCT03203057
Completed
Not Applicable

Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia

Herlev Hospital1 site in 1 country34 target enrollmentOctober 5, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Herlev Hospital
Enrollment
34
Locations
1
Primary Endpoint
Troponin release
Status
Completed
Last Updated
8 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2016
End Date
October 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asthildur Arnadottir

Medical Doctor

Herlev Hospital

Eligibility Criteria

Inclusion Criteria

  • \> 18 years of age Elective coronary angiogram Informed signed accept

Exclusion Criteria

  • Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin \> 100 µmol/L Heart Failure or LVEF \< 50 Severe Heart Valve Disease

Outcomes

Primary Outcomes

Troponin release

Time Frame: 6 hours

Quantifying troponin T and I release after ischemic event

Study Sites (1)

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