CPET in Myocardial Ischemia
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|ClinicalTrials.gov Identifier: NCT04067700|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : October 4, 2019
The investigators goal is to determine whether cardiopulmonary exercise testing (CPET) can be utilized in the diagnosis of myocardial ischemia. For the study participants the investigators will recruit patients who have been referred to myocardial perfusion PET/CT scan in Kuopio University Hospital. The participants will perform the CPET on a cycle ergometer on separate day after the perfusion scan. The investigators will compare the results of the PET/CT scan and CPET and evaluate if the possible perfusion defects detected in PET/CT correlate with the gas exchange parameters in CPET.
The patients who receive invasive coronary treatment (coronary bypass surgery or percutaneous coronary intervention) will be invited to perform additional CPET ja PET/CT tests six months after the treatment. The goal will be to determine whether the recovery of myocardial perfusion can be assessed with gas exchange parameters in CPET.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia||Procedure: Invasive coronary treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients who receive invasive coronary treatment will undergo additional coronary perfusion PET/CT and CPET tests six months after the treatment.|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia|
|Actual Study Start Date :||October 3, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||September 2028|
|Coronary perfusion PET/CT patients||
Procedure: Invasive coronary treatment
Coronary artery bypass surgery or percutaneous coronary intervention.
- Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography [ Time Frame: 6 months ]Regional myocardial perfusion below 2.3 ml/g/min measured by the quantitative positron emission tomography is a marker of myocardial ischemia
- Presence of myocardial ischemia assessed by the cardiopulmanary exercise test [ Time Frame: 6 months ]Criteria for myocardial ischemia that must be fulfilled are 1) Double sloping in the oxygen consumption/work rate trajectory, peak oxygen consumption below limit of the lowest normal, and abnormal oxygen pulse trajectory during the cardiopulmonary exercise test.
- Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing [ Time Frame: 6 months ]Positron emission tomography is the golden standard in the detection of myocardial ischemia. Results of cardiopulmary exercise testing will be compared with those of positron emission tomography using ROC-analysis. 6 months follow-up enables evaluation of reversibility of changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067700
|Contact: Tomi Laitinenemail@example.com|
|Principal Investigator:||Tomi Laitinen||Kuopio University Hospital|