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NCT Number: NCT04205110

Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)

Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. These plaques can also rupture, causing cardiovascular events such as heart attacks or strokes. By using ultrasound and infrared technology, intravascular imaging can help assess these plaques, however this is an invasive technique involving angiography. Plaque composition, structure and stability can be affected by inflammation and the stress that the arteries are under. The investigators have pioneered novel minimally-invasive methods for modelling arterial stress using computed tomography coronary angiography (CTCA), as well as imaging coronary arterial inflammation using a positron emission tomography (PET) scan. Before embarking upon a large-scale clinical outcome study to determine whether these novel methods can improve risk prediction, the aim is to perform a proof-of-principle study to further develop our methodology for hybrid image analysis, and to validate this technique against high-resolution intravascular imaging as a surrogate marker of histology.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥40
  • Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography
  • Patient that is willing and can provide written informed consent.

Exclusion criteria

  • Acute coronary syndrome within <3 months
  • Pregnancy
  • Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m²
  • Previous bypass surgery
  • Decompensated heart failure, or left ventricular ejection fraction less than 30%
  • Patient allergic to contrast or cannot receive treatment with aspirin, heparin, or thienopyridines
  • Anticipated life expectancy <2 years
  • Flow limiting coronary artery disease in the proximal segments of all the 3 epicardial coronaries
  • History of heart transplantation
  • Patient that requires surgical revascularization
  • Extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the

Treatment and study plan

PET-CT

Diagnostic Test

PET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients

Primary outcomes

  1. Faesibility of co-registration of CTCA and PET-CT data

    Time frame: 12 months

    All studied vessels will be dividen into 3 mm segments and the CTCA and PET-CT studies will be co-registered electronically. The faesibility of this will be reported

Secondary outcomes

  1. Comparing PET-CT, CTCA and intravascular imaging: plaque volume

    Time frame: 12 months

    The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque burden expressed as volume

  2. Comparing PET-CT, CTCA and intravascular imaging: plaque composition

    Time frame: 12 months

    The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque composition (reported as type of plaque)

  3. Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces

    Time frame: 12 months

    The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of haemodynamic forces including plaque and endothelial shear stress

  4. Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation

    Time frame: 12 months

    The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare assessment of markers of inflammation and vulnerability in the plaques identified

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Acronym: VALID-PET-CT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2019
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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