CPET in Myocardial Ischemia

NCT04067700 | Recruiting

• 1 other identifier: 5031365
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (1)

• Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing

  6 months

Study Arms (1)

Coronary perfusion PET/CT patients

OTHER

Procedure: Invasive coronary treatment

Interventions

Invasive coronary treatment PROCEDURE

Coronary artery bypass surgery or percutaneous coronary intervention.

Coronary perfusion PET/CT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio Univerity Hospital

Kuopio, FIN-70029, Finland

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Tomi Laitinen

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomi Laitinen

CONTACT

+358-44-7113279; tomi.laitinen@kuh.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, chief physician

Model Details: Patients who receive invasive coronary treatment will undergo additional coronary perfusion PET/CT and CPET tests six months after the treatment.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: October 3, 2019
• Primary Completion: December 1, 2022
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)