The Association Between Catheter-based Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan

NCT04973410 | Completed DMC

• 1 other identifier: 1-10-72-239-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aims

1. 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. 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.

Conditions

Coronary Artery Disease

Keywords

Thermodilution method; FFR; IMR; CFR; PET; Myocardial Blood Flow

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  From the 15O-H2O PET scan to the coronary physiology assessment during ICA, up to 1 week.

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

  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.

  From the 15O-H2O PET scan to the coronary physiology assessment during ICA, up to 1 week.

Study Arms (2)

Group A

OTHER

FFR negative/non-significant (\>0.80) and IMR negative (\<25)

Diagnostic Test: Coronary Physiology; Diagnostic Test: 15O-H2O-PET scan

Group B

OTHER

FFR negative/non-significant (\>0.80) and IMR positive (\>25)

Diagnostic Test: Coronary Physiology; Diagnostic Test: 15O-H2O-PET scan

Interventions

Coronary Physiology DIAGNOSTIC_TEST

Invasive coronary physiology measurements during diagnostic CAG with thermodilution method with the CoroFlow® (Coroventis, Uppsala, Sweden)

Also known as: IMR, FFR, CFR

Group A; Group B

15O-H2O-PET scan DIAGNOSTIC_TEST

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (13)

• Pakkal M, Raj V, McCann GP. Non-invasive imaging in coronary artery disease including anatomical and functional evaluation of ischaemia and viability assessment. Br J Radiol. 2011 Dec;84 Spec No 3(Spec Iss 3):S280-95. doi: 10.1259/bjr/50903757.

  PMID: 22723535 BACKGROUND

• Wood DJ, Mason JB, Chapman HM. Scrapie scruples. N Z Vet J. 1978 Jul;26(7):190-1. doi: 10.1080/00480169.1978.34537. No abstract available.

  PMID: 278924 BACKGROUND

• Huang SC, Schwaiger M, Carson RE, Carson J, Hansen H, Selin C, Hoffman EJ, MacDonald N, Schelbert HR, Phelps ME. Quantitative measurement of myocardial blood flow with oxygen-15 water and positron computed tomography: an assessment of potential and problems. J Nucl Med. 1985 Jun;26(6):616-25.

  PMID: 3873525 BACKGROUND

• Bergmann SR, Fox KA, Rand AL, McElvany KD, Welch MJ, Markham J, Sobel BE. Quantification of regional myocardial blood flow in vivo with H215O. Circulation. 1984 Oct;70(4):724-33. doi: 10.1161/01.cir.70.4.724.

  PMID: 6332687 BACKGROUND

• Berti V, Sciagra R, Neglia D, Pietila M, Scholte AJ, Nekolla S, Rouzet F, Pupi A, Knuuti J. Segmental quantitative myocardial perfusion with PET for the detection of significant coronary artery disease in patients with stable angina. Eur J Nucl Med Mol Imaging. 2016 Jul;43(8):1522-9. doi: 10.1007/s00259-016-3362-0. Epub 2016 Mar 18.

  PMID: 26993310 BACKGROUND

• Kajander S, Joutsiniemi E, Saraste M, Pietila M, Ukkonen H, Saraste A, Sipila HT, Teras M, Maki M, Airaksinen J, Hartiala J, Knuuti J. Cardiac positron emission tomography/computed tomography imaging accurately detects anatomically and functionally significant coronary artery disease. Circulation. 2010 Aug 10;122(6):603-13. doi: 10.1161/CIRCULATIONAHA.109.915009. Epub 2010 Jul 26.

  PMID: 20660808 BACKGROUND

• Danad I, Uusitalo V, Kero T, Saraste A, Raijmakers PG, Lammertsma AA, Heymans MW, Kajander SA, Pietila M, James S, Sorensen J, Knaapen P, Knuuti J. Quantitative assessment of myocardial perfusion in the detection of significant coronary artery disease: cutoff values and diagnostic accuracy of quantitative [(15)O]H2O PET imaging. J Am Coll Cardiol. 2014 Oct 7;64(14):1464-75. doi: 10.1016/j.jacc.2014.05.069.

  PMID: 25277618 BACKGROUND

• De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

  PMID: 22924638 BACKGROUND

• Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.

  PMID: 17531660 BACKGROUND

• Corcoran D, Young R, Adlam D, McConnachie A, Mangion K, Ripley D, Cairns D, Brown J, Bucciarelli-Ducci C, Baumbach A, Kharbanda R, Oldroyd KG, McCann GP, Greenwood JP, Berry C. Coronary microvascular dysfunction in patients with stable coronary artery disease: The CE-MARC 2 coronary physiology sub-study. Int J Cardiol. 2018 Sep 1;266:7-14. doi: 10.1016/j.ijcard.2018.04.061. Epub 2018 Apr 19.

  PMID: 29716756 BACKGROUND

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

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  PMID: 24399243 BACKGROUND

Related Links

• Fractional Flow Reserve (FFR) - Shown To Improve Patient Outcomes And Reduce Costs. October 2013

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: July 22, 2021
• Study Start: December 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)