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CPET in Myocardial Ischemia

Primary Purpose

Myocardial Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Invasive coronary treatment
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio Univerity HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coronary perfusion PET/CT patients

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2019
Last Updated
August 4, 2021
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04067700
Brief Title
CPET in Myocardial Ischemia
Official Title
Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary perfusion PET/CT patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Invasive coronary treatment
Intervention Description
Coronary artery bypass surgery or percutaneous coronary intervention.
Primary Outcome Measure Information:
Title
Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography
Description
Regional myocardial perfusion below 2.3 ml/g/min measured by the quantitative positron emission tomography is a marker of myocardial ischemia
Time Frame
6 months
Title
Presence of myocardial ischemia assessed by the cardiopulmanary exercise test
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomi Laitinen
Phone
+358-44-7113279
Email
tomi.laitinen@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomi Laitinen
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio Univerity Hospital
City
Kuopio
ZIP/Postal Code
FIN-70029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomi P Laitinen, Professor
Phone
+358-44-7113279
Email
Tomi.Laitinen@kuh.fi
First Name & Middle Initial & Last Name & Degree
Niklas Vartiainen, Dr
Phone
+358-44-7172938
Email
Niklas.Vartiainen@kuh.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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CPET in Myocardial Ischemia

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