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NCT Number: NCT04067700

CPET in Myocardial Ischemia

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.

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invasive coronary treatment

Procedure

Coronary artery bypass surgery or percutaneous coronary intervention.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tomi Laitinen

CONTACT

[email protected]

+358-44-7113279

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia

Important dates

Study start
2019
Primary completion
2022
Study completion
2028
First posted
Aug 26, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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