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Sponsored by: |
Careggi Hospital |
---|---|
Information provided by: | Careggi Hospital |
ClinicalTrials.gov Identifier: | NCT00469261 |
The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in preventing left ventricular (LV) remodeling.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction Ventricular Remodeling |
Drug: Doxycycline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study |
Estimated Enrollment: | 110 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2009 |
A myocardial interstitial matrix, that provides structural support and integrity to the myocardium, is a key element to determine post infarction left ventricular remodeling (LVR).
The metalloproteinases (MMPs), an enzymatic system secreted in the extracellular medium by macrophages, has been shown to be able to degrade the most important extracellular matrix components.
Various animal experimental models have demonstrated that MMP specific inhibition in the first phase of myocardial infarction is able to contrast LVR.
Doxycycline, a member of the tetracyclines, has been shown to block various inflammation mediators and to attenuate MMP-2 and MMP-9 expression and activity at a sub-antimicrobial dosage. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction.
In the present study we want to evaluate if a treatment with doxycycline (100 mg b.i.d.) in the first seven days after a reperfused large (ejection fraction less than 40%) acute myocardial infarction, is effective in preventing six-month LVR.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Piergiovanni Buonamici, MD | +39-055-410752 | carddept@tin.it |
Italy | |
Careggi Hospital, Department of Heart and Vessels | Recruiting |
Florence, Italy, 50100 | |
Contact: Piergiovanni Buonamici, MD +39-055-410752 carddept@tin.it |
Principal Investigator: | Giampaolo Cerisano, MD | Careggi Hospital, Florence, Italy |
Study Director: | David Antoniucci, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Piergiovanni Buonamici, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Emilio V Dovellini, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Alberto Santini, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Umberto Signorini, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Nazario Carrabba, MD | Careggi Hospital, Florence, Italy |
Study Chair: | Paolo D Pucci, MD | Careggi Hospital, Florence, Italy |
Study ID Numbers: | arcard2007/002 |
Study First Received: | May 3, 2007 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00469261 History of Changes |
Health Authority: | Italy: Ministry of Health |
Myocardial infarction Ventricular remodeling Matrix metalloproteinases Doxycycline |
Antimalarials Anti-Bacterial Agents Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Tetracycline Infarction Myocardial Infarction Doxycycline |
Anti-Infective Agents Antiprotozoal Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Vascular Diseases Enzyme Inhibitors Ischemia Tetracycline Pharmacologic Actions Antimalarials |
Anti-Bacterial Agents Protein Synthesis Inhibitors Antiparasitic Agents Necrosis Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction Doxycycline |