NCT05825859

Brief Summary

The Purpose of this study is to better understand changes in obstructive coronary artery disease in different organs other than the heart such as the brain and the kidneys using a new generation total body PET scanner.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

April 11, 2023

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perfusion in heart, brain and kidneys during rest and adenosine stress, and their associations with psychologic factors and anginal symptoms

    Multiorgan perfusion changes in patients with chest pain

    The imaging day

Secondary Outcomes (1)

  • The association between perfusion in heart, brain and kidneys, and adverse events during five year follow-up

    Five year follow-up after the imaging

Eligibility Criteria

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

Finnish people that have history of chest pain and for which there have been done CTA which shows a possibility for obstructive coronary artery disease. All people in the study population have came to a diagnostic radiowater imgaing to know if there is significant obsturction of the coronary arteries.

You may qualify if:

  • Documented history of chest pain with CT imaging showing a potential for obstructive coronary artery disease
  • Ability to sustain adenosine injection 0.14 mg/kg/min

You may not qualify if:

  • Second or third degree AV-block without pacemaker
  • Sick sinus syndrome
  • Consumption of coffee or aminophylline within 12 hours of administration
  • Recent use of dipyridmole or dipyridamole-containing medications
  • Known hypersensitivity to adenosine
  • Unstable acute MI or acute coronary artery syndrome, and prior cardiac transplantation
  • Active wheezing and bronchospasm
  • Sinus bradycardia with HR\<40 bmp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Juhani Knuuti, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juhani Knuuti, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

April 11, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations