Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements

Acute Coronary Syndrome Clinical Trial

— ICE-land  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203057
• Other study ID #: H-16027749
• Status: Completed
• Phase: N/A
• First received: June 20, 2017
• Last updated: February 20, 2018
• Start date: October 5, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: February 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Ischemia
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Other:
• coronary occlusion
percutaneous coronary intervention

Locations

Country	Name	City	State
Denmark	Herlev-Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin release	Quantifying troponin T and I release after ischemic event	6 hours