CPET in Myocardial Ischemia

Myocardial Ischemia Clinical Trial

Official title:

Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04067700
• Other study ID #: 5031365
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: September 2028

Study information

• Verified date: August 2021
• Source: Kuopio University Hospital
• Contact: Tomi Laitinen
• Phone: +358-44-7113279
• Email: tomi.laitinen[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2028
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• Invasive coronary treatment
Coronary artery bypass surgery or percutaneous coronary intervention.

Locations

Country	Name	City	State
Finland	Kuopio Univerity Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing	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.	6 months
Primary	Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography	Regional myocardial perfusion below 2.3 ml/g/min measured by the quantitative positron emission tomography is a marker of myocardial ischemia	6 months
Primary	Presence of myocardial ischemia assessed by the cardiopulmanary exercise test	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.	6 months