Groningen intervention study for the protection of heart function after a heart attack

Phase 1

• Conditions: ST-segment elevated myocardial infarction, decompensatio cordis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001006-34-NL
• Lead Sponsor: niversity Medical Centre Groningen (UMCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-26
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

1. Age = 18 years;
2. The diagnosis STEMI defined by (1) chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and (2) an electrocardiogram recording with ST- segment elevation of more than 0.1 mV in 2 or more contiguous leads or new left bundle branch block;
3. Symptoms and/or ST-segment deviation should be present (persisting) at time of arrival in the catheterization laboratory;
4. Primary percutaneous intervention is being considered as treatment;
5. Patient is willing to cooperate with follow-up during 2 years.
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 380

Exclusion Criteria

1. Prior myocardial infarction, unless maximum troponin T< 50 ng/L (STEMI/non-STEMI/acute coronary syndrome);
2. Known permanent atrial fibrillation;
3. Prior CABG;
4. Prior PCI, complicated by periprocedural infarction, unless maximum troponin T < 50ng/L;
5. Known cardiomyopathy;
6. Previous hospitalization for heart failure
7. Active malignancy (requiring chemotherapy, radiation or surgery at the time of randomization), except for adequately treated non-melanoma skin cancer or other noninvasive or in situ neoplasm (e.g., cervical cancer in situ);
8. History of chemotherapy;
9. History of radiotherapy in chest region;
10. Relieve of symptoms and complete ST-segment resolution prior to arrival at the catheterization laboratory;
11. Presentation with cardiogenic shock (systolic blood pressure < 90 mmHg);
12. Severe hypertension (systolic blood pressure > 220 mmHg);
13. Sedated and/or intubated patients;
14. The existence of a condition with a life expectancy of less than 1 year;
15. Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >;150kg; known claustrophobia; 3T MRI incompatible ferromagnetic objects in the body, end-stage renal disease);
16. Pregnancy or breastfeeding women; women of childbearing potential with clinical suspicion of possible pregnancy;
17. A condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to successfully participate in the study.

Study & Design

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