Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction (STEP-IN-AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769366
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Christian Pristipino, San Filippo Neri General Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Behavioral: Psychotherapy Drug: Medical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : June 2, 2005
Actual Primary Completion Date : November 1, 2011
Actual Study Completion Date : November 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Psychotherapy
Psychotherapy and medical therapy
Behavioral: Psychotherapy
humanistic-existential psychotherapy conducted in individual and group meetings
Active Comparator: Control
Optimal medical therapy
Drug: Medical therapy
Optimal medical therapy after Acute myocardial infarction

Primary Outcome Measures :
  1. The cumulative incidence of new cardiological events and the occurrence of new medical pathologies [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of re-hospitalisations [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI.
  • Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain.
  • Only patients in whom complete revascularization is achieved are being enrolled in the study.

Exclusion Criteria:

  • Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769366

San filippo Neri Hospital
Rome, Italy, 00135
Sponsors and Collaborators
San Filippo Neri General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christian Pristipino, MD, Head of Research and Training section, Interventional Cardiology Unit, San Filippo Neri General Hospital Identifier: NCT00769366     History of Changes
Other Study ID Numbers: 2008
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases