Cardiac Allograft VasculopathyCAVIARNCT07020039
Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
An observational study of Cardiac Allograft Vasculopathy, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
In traditional coronary artery disease, patients often experience symptoms such as angina. However, heart transplant patients lack nerve connections in the transplanted heart and therefore usually do not notice any symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 31 Aug 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult heart transplant recipients scheduled for routine coronary angiography
Who may be able to join
- Adult heart transplant recipients.
- Clinically stable and scheduled for routine ICA.
- Ability to provide informed consent
Who cannot join
- Contrast allergy
- Renal insufficiency with eGFR < 30 ml/min/m2
- Other contraindications for PCCT, ICA, or IVUS
- Acute cardiac events within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Transplant Institute
Gothenburg, Västra Götaland County, 41345
Niclas Kvarnström, MD, PhD, +46 31 3421000, niclas.kvarnstrom@vgregion.se
Markus Gabel, MD, +46 31 3421000, markus.gabel@vgregion.se
About this study
Official title: Comparing Photon Counting Computed Tomography With Invasive Coronary Angiography and Intravascular Ultrasound in Detecting Cardiac Allograft Vasculopathy
In traditional coronary artery disease, patients often experience symptoms such as angina. However, heart transplant patients lack nerve connections in the transplanted heart and therefore usually do not notice any symptoms. For this reason, routine examinations are performed using traditional coronary angiography at one, three, and six years after transplantation, sometimes with the addition of coronary ultrasound.
A new technique, photon-counting computed tomography, has now been developed and may potentially replace both traditional coronary angiography and intravascular ultrasound. In this study, we aim to investigate how well this method works in diagnosing coronary artery changes compared to the established methods.
Read the detailed description
Cardiac allograft vasculopathy (CAV) is a major cause of graft failure and mortality in heart transplant recipients. Unlike traditional atherosclerosis, CAV is characterized by diffuse intimal hyperplasia and concentric narrowing of coronary arteries, affecting both epicardial vessels and the microvasculature. The cause is largely unknown, although it is believed that both immunologic and non-immunologic factors could be at play. CAV is frequently asymptomatic due to denervation of the transplanted heart, underscoring the importance of routine surveillance to enable early and accurate detection. Such monitoring is essential to optimize post-transplant outcomes.
Invasive coronary angiography (ICA) is the gold standard for diagnosing CAV, while intravascular ultrasound (IVUS) can be considered as the gold standard for the assessment of intimal thickening and plaque burden. Photon-counting computed tomography (PCCT) represents a novel, non-invasive imaging modality with superior spatial resolution and tissue contrast compared to conventional CT systems.
A systematic comparison of PCCT with ICA and IVUS for detecting CAV has not yet been performed. This study aims to assess the diagnostic accuracy, clinical relevance, and cost-effectiveness of PCCT in comparison to ICA and IVUS. By evaluating the advantages and limitations of non-invasive versus invasive modalities, the study seeks to define the optimal surveillance strategy for CAV, ultimately guiding the management of heart transplant recipients and improving long-term outcomes.
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Heart transplantation, Cardiac allograft vasculopathy, photon counting computed tomography, Invasive coronary angiography, Intravascular ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of PCCT compared to ICA in detecting CAV
Non-invasive investigation compared to invasive procedures
Measured: 2 days
Level of agreement between PCCT and ICA in grading CAV severity
Non-invasive investigation compared with invasive procedures
Measured: 2 days
Secondary outcomes (4)
Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.
PCCT compared with IVUS
Measured: 2 days
Radiation dose exposure using PCCT contra ICA/IVUS.
Radiation dose compared between PCCT and ICA/IVUS
Measured: 2 days
Cost-effectiveness of PCCT versus ICA/IVUS
The cost of PCCT verus ICA/IVUS
Measured: 2 days
Patient comfort and procedural time differences with PCCT versus IVA/IVUS
Comparing patient comfort during PCCT and ICA/IVUS, respectively
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Kristjan Karason, Sahlgrenska University Hospital
- Investigators
- Kristjan Karason, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020039
- Sponsor's protocol ID
- CAVIAR 2025
- Acronym
- CAVIAR
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared
Publications
Pober JS, Chih S, Kobashigawa J, Madsen JC, Tellides G. Cardiac allograft vasculopathy: current review and future research directions. Cardiovasc Res. 2021 Nov 22;117(13):2624-2638. doi: 10.1093/cvr/cvab259.
PubMed 34343276Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.
PubMed 37080658Tavakol M, Ashraf S, Brener SJ. Risks and complications of coronary angiography: a comprehensive review. Glob J Health Sci. 2012 Jan 1;4(1):65-93. doi: 10.5539/gjhs.v4n1p65.
PubMed 22980117Sharma A, Cerdas MG, Reza-Soltani S, Rustagi V, Guntipalli M, Rojas Torres DS, Bhandari M, Kandel S, Teja Rayaprolu D, Hussain M. A Review of Photon-Counting Computed Tomography (PCCT) in the Diagnosis of Cardiovascular Diseases. Cureus. 2024 Nov 6;16(11):e73119. doi: 10.7759/cureus.73119. eCollection 2024 Nov.
PubMed 39650912
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Photon Counting Computed Tomography With Invasive Coronary Angiography and Intravascular Ultrasound in Detecting Cardiac Allograft Vasculopathy
- ClinicalTrials.gov ID
- NCT07020039
- Acronym / sponsor ID
- CAVIAR / CAVIAR 2025
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Heart transplantation, Cardiac allograft vasculopathy, photon counting computed tomography, Invasive coronary angiography, Intravascular ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Jun 2025 (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.
In traditional coronary artery disease, patients often experience symptoms such as angina. However, heart transplant patients lack nerve connections in the transplanted heart and therefore usually do not notice any symptoms. For this reason, routine examinations are performed using traditional coronary angiography at one, three, and six years after transplantation, sometimes with the addition of coronary ultrasound.
A new technique, photon-counting computed tomography, has now been developed and may potentially replace both traditional coronary angiography and intravascular ultrasound. In this study, we aim to investigate how well this method works in diagnosing coronary artery changes compared to the established methods.
Detailed description
Cardiac allograft vasculopathy (CAV) is a major cause of graft failure and mortality in heart transplant recipients. Unlike traditional atherosclerosis, CAV is characterized by diffuse intimal hyperplasia and concentric narrowing of coronary arteries, affecting both epicardial vessels and the microvasculature. The cause is largely unknown, although it is believed that both immunologic and non-immunologic factors could be at play. CAV is frequently asymptomatic due to denervation of the transplanted heart, underscoring the importance of routine surveillance to enable early and accurate detection. Such monitoring is essential to optimize post-transplant outcomes.
Invasive coronary angiography (ICA) is the gold standard for diagnosing CAV, while intravascular ultrasound (IVUS) can be considered as the gold standard for the assessment of intimal thickening and plaque burden. Photon-counting computed tomography (PCCT) represents a novel, non-invasive imaging modality with superior spatial resolution and tissue contrast compared to conventional CT systems.
A systematic comparison of PCCT with ICA and IVUS for detecting CAV has not yet been performed. This study aims to assess the diagnostic accuracy, clinical relevance, and cost-effectiveness of PCCT in comparison to ICA and IVUS. By evaluating the advantages and limitations of non-invasive versus invasive modalities, the study seeks to define the optimal surveillance strategy for CAV, ultimately guiding the management of heart transplant recipients and improving long-term outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult heart transplant recipients scheduled for routine coronary angiography
Key inclusion criteria (3 listed)
- Adult heart transplant recipients.
- Clinically stable and scheduled for routine ICA.
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Contrast allergy
- Renal insufficiency with eGFR < 30 ml/min/m2
- Other contraindications for PCCT, ICA, or IVUS
- Acute cardiac events within 30 days prior to enrollment.
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
Diagnostic accuracy of PCCT compared to ICA in detecting CAV
Time frame: 2 days
Non-invasive investigation compared to invasive procedures
Level of agreement between PCCT and ICA in grading CAV severity
Time frame: 2 days
Non-invasive investigation compared with invasive procedures
4 secondary outcomes
Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.
Time frame: 2 days
Radiation dose exposure using PCCT contra ICA/IVUS.
Time frame: 2 days
Cost-effectiveness of PCCT versus ICA/IVUS
Time frame: 2 days
Patient comfort and procedural time differences with PCCT versus IVA/IVUS
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 34343276Pober JS, Chih S, Kobashigawa J, Madsen JC, Tellides G. Cardiac allograft vasculopathy: current review and future research directions. Cardiovasc Res. 2021 Nov 22;117(13):2624-2638. doi: 10.1093/cvr/cvab259.
- Background: PubMed 37080658Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.
- Background: PubMed 22980117Tavakol M, Ashraf S, Brener SJ. Risks and complications of coronary angiography: a comprehensive review. Glob J Health Sci. 2012 Jan 1;4(1):65-93. doi: 10.5539/gjhs.v4n1p65.
- Background: PubMed 39650912Sharma A, Cerdas MG, Reza-Soltani S, Rustagi V, Guntipalli M, Rojas Torres DS, Bhandari M, Kandel S, Teja Rayaprolu D, Hussain M. A Review of Photon-Counting Computed Tomography (PCCT) in the Diagnosis of Cardiovascular Diseases. Cureus. 2024 Nov 6;16(11):e73119. doi: 10.7759/cureus.73119. eCollection 2024 Nov.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared
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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.
Kristjan Karason, MD, PhD principal investigator
Sahlgrenska 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 Cardiac Allograft Vasculopathy, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Jun 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristjan Karason, MD, PhD (+46 739401560, kristjan.karason@vgregion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of PCCT compared to ICA in detecting CAV (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07020039, which also lists 4 linked publications.
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 13 Jun 2025.