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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Pristipino, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT00769366
First received: October 7, 2008
Last updated: April 28, 2017
Last verified: April 2017
  Purpose

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
Acute Myocardial Infarction Behavioral: Psychotherapy Drug: Medical therapy

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Christian Pristipino, San Filippo Neri General Hospital:

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

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

Enrollment: 101
Study Start Date: June 2, 2005
Study Completion Date: November 1, 2016
Primary Completion Date: November 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769366

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Pristipino, MD, Head of Research and Training section, Interventional Cardiology Unit, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier: NCT00769366     History of Changes
Other Study ID Numbers: 2008
Study First Received: October 7, 2008
Last Updated: April 28, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017