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CPET in Myocardial Ischemia

Sponsor
Kuopio University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04067700
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
107
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Invasive coronary treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Oct 3, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Other: Coronary perfusion PET/CT patients

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Other Outcome Measures

  1. Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kuopio Univerity Hospital Kuopio Finland FIN-70029

Sponsors and Collaborators

  • Kuopio University Hospital

Investigators

  • Principal Investigator: Tomi Laitinen, Kuopio University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomi Laitinen, Professor, chief physician, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT04067700
Other Study ID Numbers:
  • 5031365
First Posted:
Aug 26, 2019
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Myocardial Ischemia
Coronary Artery Disease
Ischemia

Study Results

No Results Posted as of Aug 5, 2021