Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult heart transplant recipients.

Clinically stable and scheduled for routine ICA.

Ability to provide informed consent

Disqualifiers

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 population

Adult heart transplant recipients scheduled for routine coronary angiography

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of PCCT compared to ICA in detecting CAV

Non-invasive investigation compared to invasive procedures

Time frame
2 days
2

Level of agreement between PCCT and ICA in grading CAV severity

Non-invasive investigation compared with invasive procedures

Time frame
2 days

Secondary outcomes

1

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

PCCT compared with IVUS

Time frame
2 days
2

Radiation dose exposure using PCCT contra ICA/IVUS.

Radiation dose compared between PCCT and ICA/IVUS

Time frame
2 days
3

Cost-effectiveness of PCCT versus ICA/IVUS

The cost of PCCT verus ICA/IVUS

Time frame
2 days
4

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

Comparing patient comfort during PCCT and ICA/IVUS, respectively

Time frame
2 days

Other outcomes

1

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

To see whether periarterial fat density and myocardial fibrosis are related to CAV

Time frame
1 day

Sponsors and contacts

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Sahlgrenska University Hospital

Lead sponsor

Göteborg University

Collaborator

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