Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
145
Countries
1
Sites
4
Myocardial infarction with non-obstructive coronary arteries (MINOCA)
To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved quality of life outcomes.
Key facts
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 2 Sep 2021 → 30 Jun 2025
- Decision date (initial)
- 2024-11-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministero della Salute (Project code: GR-2019-12370197)
External identifiers
- EU CT number
- 2024-518724-72-00
- EudraCT number
- 2020-006009-43
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Efficacy, Safety
To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved quality of life outcomes.
Secondary objectives 4
- To evaluate if the use of a precision-medicine approach with a specific therapy tailored on the MINOCA pathogenic mechanism will improve the prognosis
- To assess if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in reducing healthcare related costs
- To test wherever a plasma circulating biomarker profile may be able to differentiate between the different causes of MINOCA, helping to identify the underlying pathophysiological mechanisms and to stratify prognosis and response to medical therapy
- To test wherever cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification in MINOCA
Conditions and MedDRA coding
Myocardial infarction with non-obstructive coronary arteries (MINOCA)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Ability to give informed consent to the study
- Age > 18y
- MINOCA diagnosis, defined as: - Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria): - Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel. - No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).
Exclusion criteria 7
- Inability or limited capacity to give informed consent to the study
- Age < 18 y
- Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. “Highly effective contraceptive” is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
- Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded
- Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non–CMR-compatible pacemaker or defibrillator
- Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease
- Patients with comorbidities having an expected survival <1-year will be excluded
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
Secondary endpoints 4
- Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) at 1-year follow-up in MINOCA patients
- Healthcare primary and secondary related-costs (including costs for tests, procedures and outpatient visits or medicines) and socioeconomic burden of MINOCA patients
- Ability of different circulating biomarkers (ET-1, NPY, CRP, sCD40L and miRNA [miR-16, miR-26a, miR-145, miR-222, miR-155-5p, miR-483-5p and miR-451]) as diagnostic biomarker and stratification tool for specific causes of MINOCA
- Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
SUB00090MIG · Substance
- Active substance
- Warfarin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10248MIG · Substance
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13997MIG · Substance
- Active substance
- Glyceryl Trinitrate
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07148MIG · Substance
- Active substance
- Diltiazem
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13395MIG · Substance
- Active substance
- Clopidogrel
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13096MIG · Substance
- Active substance
- Bisoprolol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05228MIG · Substance
- Active substance
- Acetylcholine Chloride
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INTRAOCULAR IRRIGATION
- Route of administration
- INTRAARTERIAL USE
- Max daily dose
- 200 µg microgram(s)
- Max total dose
- 200 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB34053 · Substance
- Active substance
- Lysine Aspirin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.9 g gram(s)
- Max total dose
- 0.9 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Address
- Largo Francesco Vito 1
- City
- Rome
- Postcode
- 00168
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Rocco Antonio Montone
Public contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Rocco Antonio Montone
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 145 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC di Terapia intensiva Cardiologica, Largo Francesco Vito 1, 00168, Rome
Centro Cardiologico Monzino S.p.A.
UOC Terapia Intensiva Cardiologica, Via Carlo Parea 4, 20138, Milan
Policlinico San Donato S.p.A.
Cardiologia interventistica ed Emodinamica, Piazza Edmondo Malan 2, 20097, San Donato Milanese
University Hospital Of Ferrara
Cardiologia, Cona, Via Aldo Moro 8, Ferrara
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2021-09-02 | 2021-09-02 | 2024-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final trial publication SUM-111601
|
2025-12-17T11:53:14 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2026-02-05T17:33:26 | Submitted | Laypersons Summary of Results |
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay person summary of results_EU CT Number 2024-518724-72-00 | 1 |
| Protocol (for publication) | D1_Protocol EU CT Number 2024-518724-72-00 | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consenso trattamento dati centro partecipante | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consenso trattamento dati promotore | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmP_Warfarin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Acetylcholine chloride | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Acetylsalicylic acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Atorvastatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bisoprolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Diltiazem | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lysine acetylsalicylate | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nitroglycerin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ramipril | 1 |
| Summary of results (for publication) | Final Study Publication_PROMISE study | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_EU CT Number 2024-518724-72-00 | 5 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Italy | Acceptable 2024-11-12
|
2024-11-26 |