Total Body Perfusion in Patients With Chest Pain (KOVERI)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

Detailed Description

Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Juhani Knuuti, MD; Phone Number: +358500592998; Email: juhani.knuuti@tyks.fi

Study Locations

• Finland
  • Turku, Finland, 20520
    • Recruiting
    • Turku University Hospital
    • Contact: Juhani Knuuti, MD; Phone Number: +358500592998; Email: juhani.knuuti@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Five year follow-up after the imaging

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Juhani Knuuti, MD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Chest Pain
• Other Study ID Numbers: KOVERI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No