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The Association Between Catheter-based Absolute Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan Based Absolute Myocardial Blood Flow in the Coronary Artery Territory (FLOW3)

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ClinicalTrials.gov Identifier: NCT04973410
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Department of Nuclear Medicine, Aarhus University Hospital
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital

Brief Summary:

Aims

  1. To assess the correlation between absolute flow and resistance assessed by catheter-based thermodilution technique using CoroFlow®-system and myocardial blood flow (MBF) measured by positron emission tomography (PET) and the tracer [15O] labeled water ([15O]H2O) (15O-H2O PET)
  2. To assess the correlation between impaired MBF measured with 15O-H2O PET and negative fractional flow reserve (FFR) and index of microvascular resistance (IMR) level.

Hypothesis:

In patients with angina pectoris and reduced MBF measured with 15O-H2O PET but no hemodynamic significant stenosis (FFR > 0.80), the IMR is >25 measured with continuous thermodilution indicating microcirculatory dysfunction.

Methods:

We include patients with angina pectoris and suspected coronary disease based on a cardiac-computerised tomography (CT) scan. Patients are then referred to an 15O-H2O PET (rest and stress) and then a diagnostic invasive coronary angiography (ICA) with physiological assessment.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diagnostic Test: Coronary Physiology Diagnostic Test: 15O-H2O-PET scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FLOW 3 - The Association Between Catheter-based Absolute Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan-based Absolute Myocardial Blood Flow in the Coronary Artery Territory.
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Group A
FFR negative/non-significant (>0.80) and IMR negative (<25)
Diagnostic Test: Coronary Physiology
Invasive coronary physiology measurements during diagnostic CAG with thermodilution method with the CoroFlow® (Coroventis, Uppsala, Sweden)
Other Name: IMR, FFR, CFR

Diagnostic Test: 15O-H2O-PET scan
Myocardial blood flow (MBF) measured with oxygen-15 (O-15) labelled water used as a tracer molecule with positron emission tomography (PET)

Group B
FFR negative/non-significant (>0.80) and IMR positive (>25)
Diagnostic Test: Coronary Physiology
Invasive coronary physiology measurements during diagnostic CAG with thermodilution method with the CoroFlow® (Coroventis, Uppsala, Sweden)
Other Name: IMR, FFR, CFR

Diagnostic Test: 15O-H2O-PET scan
Myocardial blood flow (MBF) measured with oxygen-15 (O-15) labelled water used as a tracer molecule with positron emission tomography (PET)




Primary Outcome Measures :
  1. Sensitivity, specificity for absolute myocardial blood flow measured by 15O-H2O PET in detection of coronary microcirculatory diseases measured by index of microcirculatory index (IMR) [ Time Frame: From the 15O-H2O PET scan to the coronary physiology assessment during ICA, up to 1 week. ]

    Sensitivity, specificity for absolute myocardial blood flow measured by 15O-H2O PET in detection of coronary microcirculatory diseases measured by index of microcirculatory index (IMR) during catheter-based thermodilution technique.

    The diagnostic performance of 15O-H2O PET between low and high IMR groups


  2. The diagnostic performance of 15O-H2O PET between low and high IMR groups [ Time Frame: From the 15O-H2O PET scan to the coronary physiology assessment during ICA, up to 1 week. ]
    positive predictive value (PPV), negative predictive value (NPV) for absolute myocardial blood flow measured by 15O-H2O PET in detection of coronary microcirculatory diseases measured by index of microcirculatory index (IMR) during catheter-based thermodilution technique.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to diagnostic ICA after heart-CT
  • Able to provide an informed consent.
  • Age ≥ 18 years

Exclusion Criteria:

  • PCI, CABG, POBA or already acknowledge ischemic heart disease
  • Acute coronary disease or AMI
  • COPD or Asthma
  • Pregnancy and breast breeding
  • Contraindications to adenosine (severe asthma, complicated AV block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
  • Renal impairment with estimated glomerular filtration rate (eGFR) <40 ml / min.
  • Allergy to X-ray contrast agents or severe metabolic disease.
  • Donor heart, mechanical heart, or mechanical heart pump

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973410


Contacts
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Contact: Evald H Christiansen, MD +4561655176 evald.christiansen@dadlnet.dk
Contact: Salma R Karim, PHD +4560599675 salabd@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Evald H Christiansen, MD    +4561655176    evald.christiansen@dadlnet.dk   
Contact: Salma R Karim, PHD    +4560599675    salabd@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital Skejby
Department of Nuclear Medicine, Aarhus University Hospital
Additional Information:
Publications:

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Responsible Party: Evald Hoej Christiansen, Clinical Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04973410    
Other Study ID Numbers: 1-10-72-239-19
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evald Hoej Christiansen, Aarhus University Hospital:
Thermodilution method
FFR
IMR
CFR
PET
Myocardial Blood Flow
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases