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NCT Number: NCT04451551

Myocardial Perfusion Imaging by 15O-H2O PET/CT

The trial will include 5000 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo the clinical scan as normal.

Data from the scans will be used to determine reference values of the examination.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location status: Recruiting

Location contact

Simon Madsen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital

Exclusion criteria

  • Claustrophobia, severe asthma, younger than 18 years

Treatment and study plan

Primary outcomes

  1. Prognostic value within 10 years

    Time frame: 10 years

    Number of participants who experience a major adverse cardiac event within 10 years of follow-up.

Secondary outcomes

  1. Myocardial blood flow

    Time frame: 5 Years

    The myocardial blood flow of participants assessed by 15O-H2O PET/CT

  2. Coronary flow reserve

    Time frame: 5 Years

    The coronary flow reserve of participants assessed by 15O-H2O PET/CT

  3. Pulmonary transit time

    Time frame: 5 Years

    The pulmonary transit time of participants assessed by 15O-H2O PET/CT

  4. Left ventricular end-systolic volume

    Time frame: 5 Years

    The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT

  5. Left ventricular end-diastolic volume

    Time frame: 5 Years

    The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT

  6. Right ventricular end-systolic volume

    Time frame: 5 Years

    The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT

  7. Right ventricular end-diastolic volume

    Time frame: 5 Years

    The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT

  8. Immediate coronary angiography followup

    Time frame: 5 years

    Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT

  9. Immediate percutaneous coronary intervention (PCI) followup

    Time frame: 5 years

    Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT

  10. Immediate coronary artery bypass graft (CABG) followup

    Time frame: 5 years

    Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT

  11. Prognostic value within 5 years

    Time frame: 5 years

    Number of participants who experience a major adverse cardiac event within 5 years of follow-up.

  12. Prognostic value within 2 years

    Time frame: 2 years

    Number of participants who experience a major adverse cardiac event within 2 years of follow-up.

  13. Prognostic value within 1 years

    Time frame: 1 years

    Number of participants who experience a major adverse cardiac event within 1 years of follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Madsen, MD

CONTACT

[email protected]

4520140596+

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value

Important dates

Study start
2020
Primary completion
2026
Study completion
2036
First posted
Jun 30, 2020
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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