Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
78
Countries
1
Sites
1
Coronary artery chronic total occlusion
Evaluate the concordance between coronary CT angiography with myocardial perfusion imaging at stress and rest and stress cardiac MRI for the detection of ischemia and viability in patients with chronic total occlusion (CTO).
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-10
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519979-26-00
- EudraCT number
- 2022-001452-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Evaluate the concordance between coronary CT angiography with myocardial perfusion imaging at stress and rest and stress cardiac MRI for the detection of ischemia and viability in patients with chronic total occlusion (CTO).
Secondary objectives 2
- Evaluate the concordance between stress cardiac MRI without contrast using native myocardial T1 mapping and conventional stress cardiac MRI with contrast for the detection of ischemia in patients with coronary CTO.
- Compare the modification of the arrhythmogenic substrate, including both myocardial ischemia and scar characterization, using cardiac MRI before and after percutaneous revascularization of a coronary CTO.
Conditions and MedDRA coding
Coronary artery chronic total occlusion
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10076311 | Chronic disease | 100000004867 |
| 20.0 | PT | 10011086 | Coronary artery occlusion | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Chronic total occlusion in a native coronary artery
- Age 18 years or older
- Distal vessel to the chronic occlusion with a diameter of at least 2.5 mm
- Ability to provide informed consent and willingness to comply with the follow-up protocol
Exclusion criteria 11
- Multivessel disease with incomplete revascularization in the artery without chronic total occlusions.
- Previous revascularization surgery in the artery with chronic total occlusion.
- Acute myocardial infarction within the past 3 months.
- Coronary anatomy not favorable for percutaneous revascularization of the chronic total occlusion.
- Coronary artery disease involving the left main or three vessels requiring surgery as assessed by the multidisciplinary team.
- Life expectancy less than 2 years.
- Severe chronic renal insufficiency (glomerular filtration rate ≤ 30 mL/min).
- Contraindication to dual antiplatelet therapy.
- Pregnancy.
- Severe valvular disease requiring surgery.
- Allergy to iodinated contrast.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Viability: -Enhancement Criterion: mean late enhancement in more than 50% of the thickness of the affected myocardial wall using the 17-segment model. Number of segments meeting this criterion. -Myocardial Thickness Criterion: mean myocardial thickness less than 5 or 3 mm in segments with motility impairment. Number of segments meeting this criterion.
- Myocardial Ischemia: Inducible and persistent perfusion defect during the stress study that significantly improves or completely resolves in the rest study and exceeds the lateral or transmural extent of myocardial scar in the late enhancement study in the same myocardial segment. Number of segments with myocardial ischemia.
- Chronic Total Occlusion (CTO): Absence of antegrade coronary flow through the coronary stenosis. There may be flow through ipsilateral collaterals as long as there is no flow through the lesion. The CTO will be classified as definite if there is evidence of an occlusion lasting more than three months. If there is no evidence regarding the duration of the occlusion, it will be classified as probable.
Secondary endpoints 5
- Cardiac Magnetic Resonance Imaging (CMR): A baseline study will be performed and 6 months after the intervention according to routine clinical practice. All studies will be conducted on a 3T system (ARCHITECT GE).
- Computed Tomography: A Computed Tomography study will be performed as part of routine clinical practice within the pre-procedural evaluation of percutaneous coronary revascularization. A protocol will be conducted that includes a static perfusion assessment at stress and rest, coronary angiography, and late enhancement for viability evaluation. A dual-source scanner with dual-energy capability (Somaton Flash Definition, SIEMENS) will be used.
- Adverse Events: The definitions provided by the Chronic Total Occlusion Academic Research Consortium (CTO-ARC) will be used.
- Arrhythmogenic Substrate: The evaluation of the arrhythmogenic substrate will be performed using late enhancement images obtained through a 3D Inversion-Recovery Gradient Echo sequence with free-breathing and respiratory navigator. The ADAS 3D software from Galgo Medical SL with CE marking will be used.
- Invasive Physiological Assessment: Invasive physiological assessment will be performed in all patients according to routine clinical practice with the aim of optimizing percutaneous treatment. Follow-up catheterization with invasive physiological assessment in patients with distal stenosis to the occlusion ≥ 50% will also be performed according to routine clinical practice (substudy of invasive coronary physiology).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Rapiscan 400 microgram solution for injection
PRD6258929 · Product
- Active substance
- Regadenoson
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 400 µg microgram(s)
- Max total dose
- 400 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01EB21 — -
- Marketing authorisation
- EU/1/10/643/001
- MA holder
- GE HEALTHCARE AS
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Clariscan 0,5 mmol/mL solución inyectable EFG
PRD4848584 · Product
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA02 — GADOTERIC ACID
- Marketing authorisation
- 81884
- MA holder
- GE HEALTHCARE BIO-SCIENCES, S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Eufilina Venosa 200 mg solución inyectable
PRD9169367 · Product
- Active substance
- Theophylline Anhydrous
- Substance synonyms
- THEOPHYLLINE (ANHYDROUS), ANHYDROUS THEOPHYLLINE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- R03DA04 — THEOPHYLLINE
- Marketing authorisation
- 1.891
- MA holder
- ZR PHARMA& GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr. Ander Regueiro
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr. Ander Regueiro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 78 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519979-26-00_redacted | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SP_adults_redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clariscan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Regadenoson | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Spain | Acceptable 2025-01-10
|
2025-01-10 |