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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
Sponsor:
Information provided by (Responsible Party):
Tomi Laitinen, Kuopio University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coronary perfusion PET/CT patients Procedure: Invasive coronary treatment
Coronary artery bypass surgery or percutaneous coronary intervention.




Primary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referral to coronary perfusion PET/CT scan in Kuopio University Hospital

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy or breastfeeding
  • Handicap
  • Imprisonment
  • Care under forensic psychiatry

Information from the National Library of Medicine

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


Contacts
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Contact: Tomi Laitinen +358-44-7113279 tomi.laitinen@kuh.fi

Locations
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Finland
Kuopio Univerity Hospital Recruiting
Kuopio, Finland, FIN-70029
Contact: Tomi P Laitinen, Professor    +358-44-7113279    Tomi.Laitinen@kuh.fi   
Contact: Niklas Vartiainen, Dr    +358-44-7172938    Niklas.Vartiainen@kuh.fi   
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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Principal Investigator: Tomi Laitinen Kuopio University Hospital
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Responsible Party: Tomi Laitinen, Professor, chief physician, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT04067700    
Other Study ID Numbers: 5031365
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases