Clinical trial in patients who have suffered a heart attack and who have undergone catheterization treated with mild-simendan.

Phase 1

• Conditions: acute coronary syndrome with ST-segment elevation; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-003843-39-ES
• Lead Sponsor: Hospital Universitario de Canarias- Dr. Francisco Bosa Ojeda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Patients of both sexes who come to CHUC.
Age between 18 and 85 years old.
Symptoms of STEMI over 30 minutes and less than 12 hours of evolution.
ST segment elevation of >= 1 mm in two contiguous limb leads or >= 2 mm in two contiguous precordial leads.
That they agreed to participate in the study and have signed the informed consent.
The same patient may not be included more than once.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Class Killip IV in cardiogenic shock situation or with Arterial Pressure below 80 mmHg systolic pressure.
That they had a previous heart attack.
who don't have contractility disorders on their left ventriculography.
Mental circumstance that makes you unable to participate in the study.
Refuse to participate in the study and not sign an informed consent form.
Severe renal failure (creatinine clearance < 30ml/min)
Severe liver failure (define).
History of Torsades de Pointes.
Acute respiratory distress
Allergy to levosimendan or some of its components
Anemia (hemoglobin < 8g/dl)
Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified