Prognostic Performance of Quantitative Myocardial Perfusion Imaging Using H2[15O] Positron Emission Tomography in Coronary Artery Disease - The AQUA COR trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Therapy

The primary objective for the main basket cohort is to determine prognostic thresholds for predicting major adverse cardiovascular events-1 (MACE) in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.

Secondary objectives 4

1. To determine subgroup-specific prognostic thresholds in the main basket cohort for predicting MACE-1 in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.
2. To identify prognostic thresholds in the main basket cohort for predicting MACE-2 in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.
3. To establish subgroup-specific prognostic thresholds in the main basket cohort for predicting MACE-2 in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.
4. To determine prognostic thresholds in the main basket cohort for predicting individual cardiovascular and non-cardiovascular events in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.

Conditions and MedDRA coding

Cardiovascular disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed written consent.
2. Female and male subjects ≥ 18 years.
3. Clinically suspected or known CAD.
4. Clinical indication for MPI in alignment with current evidence-based practice, clinical guidelines, and/or local routines (applies to both the main basket cohort and the additional basket cohorts A - D and F - H).
5. In case of the additional basket cohorts, subjects must meet one of the following additional criteria: A) Antianginal treatment basket cohort High pretest probability of CAD, angina pectoris as the primary symptom, no or recently initiated or inadequate antianginal treatment that can be withheld for a duration equivalent to 3 - 5 drug half-lives, and no prior history of coronary intervention. B) Heart failure treatment basket cohort Newly diagnosed idiopathic dilated cardiomyopathy and no or recently initiated heart failure therapy. C) TAVI basket cohort Severe aortic stenosis accepted for TAVI. D) CTO basket cohort Coronary CTO eligible for 1) optimized medical treatment alone, 2) PCI, or 3) reducer stent implantation. E) Anti-inflammatory treatment basket cohort Cardiac sarcoidosis with an indication for anti-inflammatory treatment. F) CKD basket cohort CKD of varying severity, defined as eGFR < 60 ml/min/1.73 m2, not receiving maintenance dialysis at baseline. G) Long-term dialysis basket cohort Maintenance dialysis in end-stage CKD. H) Kidney transplantation basket cohort End-stage CKD under evaluation for kidney transplantation. I) Takotsubo syndrome basket cohort Classic, hemodynamically stable acute Takotsubo syndrome. J) STEMI basket cohort Recently revascularized acute STEMI.

Exclusion criteria 4

1. Contraindications for the used pharmacological stress agents.
2. Contraindications for PET/CT or PET/MR, such as severe claustrophobia or non-MR-conditional implants.
3. Inability to understand and adhere to all study-related procedures, including participant preparation.
4. Pregnancy or lactation. All female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or inconclusive, a serum pregnancy test will be required. For any serial H2[15O] PET studies, this procedure has to be performed before every single scan.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.

Secondary endpoints 4

1. Time to first occurrence of MACE-1 in the main basket cohort, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
2. Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
3. Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
4. Time to first occurrence of individual cardiovascular and non-cardiovascular events in the main basket cohort during a follow-up period of up to 10 years. These events include the individual components of MACE-1 and -2, hospitalization for unstable angina, hospitalization for heart failure, and unplanned ischemia-driven revascularization (PCI/CABG), with a 90-day blanking period applied to revascularization events. For risk-prediction analyses, 2- and 5-year time horizons will be applied.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Christian Polte

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Christian Polte

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications