MAMI Use of the Methoxyflurane as pain-killer in the prehospital management of Acute Myocardial Infarction

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-06-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Programme Hospitalier de Recherche Clinique

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that methoxyflurane self-administered by the patient suffering chest pain related to an acute myocardial infarction is at least as efficient in achieving pain relief that morphine with better tolerance.

Secondary objectives 2

1. To compare the impact of the treatments on cardiovascular system
2. To compare tolerance of the treatments, particularly respiratory depression and sedation

Conditions and MedDRA coding

Acute Myocardial Infarction

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patient age ≥ 18 years
2. Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI) : Douleur thoracique < 12 heures avec douleur modérée à sévère (EVA > 6/10).
3. Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI): STEMI on EKG according to 2018 ESC guidelines

Exclusion criteria 20

1. Previous analgesic treatment for this episode of chest pain
2. Contra-indication to morphine or methoxuflurane administration
3. Incapacity to self-assess pain intensity
4. Incapacity to methoxyflurane self-administration
5. Pregnancy, minors or incapacity (tutelle, curatelle)
6. Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
7. Absence of a Social Security
8. Clinical evidence of respiratory depression.
9. Decompensated respiratory failure (in the absence of artificial ventilation),
10. - Clinical evidence of cardiovascular instability (PAS <90 mm Hg)
11. Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.
12. Clinically significant renal impairment.
13. History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.
14. Severe hepatocellular insufficiency (with encephalopathy),,
15. Acute head trauma and intracranial hypertension in the absence of controlled ventilation,
16. Uncontrolled epilepsy
17. Treatment with buprenorphine, nalbuphine and pentazocine, xyrem, naltrexone,
18. Breastfeeding, in case of initiation or continuation after birth of a long-term treatment.
19. Malignant hyperthermia: known malignant hyperthermia or genetic predisposition of the patient.
20. History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.

Secondary endpoints 6

1. Pain relief: time before achieving pain relief, i.e. time between randomization and pain intensity score on VAS ≤ 3;
2. Pain relief: time to reach initial pain divided by two (initial VAS / 2)
3. Impact of the treatments on cardiovascular system: heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival
4. Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes
5. Tolerance of the treatments: sedation: Richmond Agitation - Sedation Scale (RASS) ≥ 2 or ≤ -2
6. Tolerance of the treatments: : dizziness, pruritus, nausea, vomiting, headache

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Frédéric LAPOSTOLLE

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Frédéric LAPOSTOLLE

Locations

1 EU/EEA country · 10 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 13 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