Coronary Artery DiseaseKOVERINCT05825859
Total Body Perfusion in Patients With Chest Pain
An observational study of Coronary Artery Disease, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 11 Apr 2023to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20520
Juhani Knuuti, MD, +358500592998, juhani.knuuti@tyks.fi
About this study
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.
Read the detailed description
Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The imaging day
Secondary outcomes (1)
The association between perfusion in heart, brain and kidneys, and adverse events during five year follow-up
Multiorgan perfusion changes in patients with chest pain as related to outcome
Measured: Five year follow-up after the imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start11 Apr 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juhani Knuuti, Turku University Hospital
- Investigators
- Juhani Knuuti, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825859
- Sponsor's protocol ID
- KOVERI
- Acronym
- KOVERI
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Body Perfusion in Patients With Chest Pain
- ClinicalTrials.gov ID
- NCT05825859
- Acronym / sponsor ID
- KOVERI / KOVERI
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion in heart, brain and kidneys during rest and adenosine stress, and their associations with psychologic factors and anginal symptoms
Time frame: The imaging day
Multiorgan perfusion changes in patients with chest pain
1 secondary outcome
The association between perfusion in heart, brain and kidneys, and adverse events during five year follow-up
Time frame: Five year follow-up after the imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhani Knuuti, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juhani Knuuti, MD (+358500592998, juhani.knuuti@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion in heart, brain and kidneys during rest and adenosine stress, and their associations with psychologic factors and anginal symptoms (time frame: The imaging day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.