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Sponsored by: |
San Filippo Neri General Hospital |
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Information provided by: | San Filippo Neri General Hospital |
ClinicalTrials.gov Identifier: | NCT00769366 |
Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.
The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.
Condition | Intervention |
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Acute Myocardial Infarction |
Behavioral: Psychotherapy Drug: Medical therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Controlled Study on Short-Term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction) |
Estimated Enrollment: | 92 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Psychotherapy: Experimental
Psychotherapy and medical therapy
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Behavioral: Psychotherapy
humanistic-existential psychotherapy conducted in individual and group meetings
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Control: Active Comparator
Optimal medical therapy
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Drug: Medical therapy
Optimal medical therapy after Acute myocardial infarction
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adriana Roncella, MD | +390633061 | adrianaroncella@hotmail.it |
Italy | |
San filippo Neri Hospital | Recruiting |
Rome, Italy, 00135 | |
Contact: Adriana Roncella, MD +090633061 adrianaroncella@hotmail.it |
Responsible Party: | San Filippo Neri Hospital ( Adriana Roncella, MD ) |
Study ID Numbers: | 2008 |
Study First Received: | October 7, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00769366 |
Health Authority: | Italy: Ethics Committee |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |