Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy

NCT07020039 | Not Yet Recruiting

• 1 other identifier: CAVIAR 2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Allograft Vasculopathy

Keywords

Heart transplantation; Cardiac allograft vasculopathy; photon counting computed tomography; Invasive coronary angiography; Intravascular ultrasound

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of PCCT compared to ICA in detecting CAV

  Non-invasive investigation compared to invasive procedures

  2 days

• Level of agreement between PCCT and ICA in grading CAV severity

  Non-invasive investigation compared with invasive procedures

  2 days

Secondary Outcomes (4)

• Correlation between PCCT and IVUS in quantifying lumen area, wall thickness, and plaque burden.

  2 days

• Radiation dose exposure using PCCT contra ICA/IVUS.

  2 days

• Cost-effectiveness of PCCT versus ICA/IVUS

  2 days

• Patient comfort and procedural time differences with PCCT versus IVA/IVUS

  2 days

Other Outcomes (1)

• Relationship between CAV and periarterial fat density as well as myocardial fibrosis

  1 day

Eligibility Criteria

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

Study Population

Adult heart transplant recipients scheduled for routine coronary angiography

You may qualify if:

• Adult heart transplant recipients.
• Clinically stable and scheduled for routine ICA.
• Ability to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Transplant Institute

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (4)

• 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.

  PMID: 34343276 BACKGROUND

• Velleca 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.

  PMID: 37080658 BACKGROUND

• Tavakol 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.

  PMID: 22980117 BACKGROUND

• Sharma 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.

  PMID: 39650912 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Proteomics

Study Officials

• Kristjan Karason, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristjan Karason, MD, PhD

CONTACT

+46 739401560; kristjan.karason@vgregion.com

Entela Bollano, MD, PhD

CONTACT

+46 70 7910635; entela.bollano@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 1 2028
• Access Criteria: Reasonable request

Locations

SE (1)