NCT04451551

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
121mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jun 2020Aug 2036

First Submitted

Initial submission to the registry

June 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2036

Expected
Last Updated

January 24, 2024

Status Verified

January 1, 2023

Enrollment Period

6.1 years

First QC Date

June 23, 2020

Last Update Submit

January 22, 2024

Conditions

Ischemic Heart Disease

Keywords

Myocardial Perfusion ImagingPositron-Emission TomographyCoronary Artery DiseaseCoronary Flow ReserveMyocardial Blood FlowPrognosisReference Value

Outcome Measures

Primary Outcomes (1)

  • Prognostic value within 10 years

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

    10 years

Secondary Outcomes (13)

  • Myocardial blood flow

    5 Years

  • Coronary flow reserve

    5 Years

  • Pulmonary transit time

    5 Years

  • Left ventricular end-systolic volume

    5 Years

  • Left ventricular end-diastolic volume

    5 Years

  • +8 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.

You may qualify if:

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

You may not qualify if:

  • Claustrophobia, severe asthma, younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Simon Madsen, MD

CONTACT

4520140596+simmas@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 30, 2020

Study Start

June 23, 2020

Primary Completion

August 1, 2026

Study Completion (Estimated)

August 1, 2036

Last Updated

January 24, 2024

Record last verified: 2023-01

Locations

DK(1)