CPET in Myocardial Ischemia

Not Applicable

Recruiting

• Conditions: Myocardial Ischemia
• Interventions: Procedure: Invasive coronary treatment

• Registration Number: NCT04067700
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2019-10-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-12
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary perfusion PET/CT patients	Invasive coronary treatment	-

Primary Outcome Measures

Name	Time	Method
Presence of myocardial ischemia assessed by the cardiopulmanary exercise test	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.
Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography	6 months	Regional myocardial perfusion below 2.3 ml/g/min measured by the quantitative positron emission tomography is a marker of myocardial ischemia

Trial Locations

Locations (1)

Kuopio Univerity Hospital; 🇫🇮 Kuopio, Finland