Anterior Wall Myocardial Infarction, Heart Failure, Remodeling, Ventricular, ST Elevation Myocardial Infarction
Conditions
Keywords
Doxycycline, Cardiac Remodelling, STEMI
Brief summary
Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.
Interventions
DRUGDoxycycline 100Mg Capsule
Doxycycline capsule
DRUGPlacebo oral capsule
Capsule manufactured to mimic doxycycline 100 mg capsule
Sponsors
National Cardiovascular Center Harapan Kita Hospital Indonesia
Felix Chikita Fredy, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The only party who is not masked is the pharmacist
Intervention model description
One arm receives standard care after primary PCI, the other receives doxycycline b.i.d for 7 days as an adjunct to standard care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Onset of STEMI \<12 hours * Anterior wall STEMI or Killip grade II-III or LVEF \<50% * Undergoing primary PCI
Exclusion criteria
* Signs of infection (clinical judgement plus leukocyte count \>15,000) * STEMI mechanical complication * Moderate-severe valvular disease * Allergic to doxycycline * Refuse to join the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ST2 | 24 hours | ST2 in ng/ml |
| high sensitivity-Troponin T | 12 hours | hs-Troponin T in ng/L |
| high sensitivity-CRP | 24 hours | hs-CRP in mg/L |
| NT-pro BNP | 5 days | NT-pro BNP in pg/ml |
| netrophils | 24 hours | absolute amount per micro liters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure incidence | 4 months | Evaluating the occurrence of heart failure signs and/or symptoms |
| Re-hospitalization rate | 4 months | The number of patients re-admitted due to heart failure signs and/or symptoms |
| Left ventricle function and dimension | 4 months | Assessed through echocardiography |
| Mortality rate | 4 months | The number of deceased participants |
Countries
Indonesia
Contacts
Primary ContactBambang Widyantoro, PhD
Backup ContactFelix C Fredy, MD
Outcome results
None listed