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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by San Filippo Neri General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT00769366
First received: October 7, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of re-hospitalisations [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769366

Contacts
Contact: Adriana Roncella, MD +390633061 adrianaroncella@hotmail.it

Locations
Italy
San filippo Neri Hospital Recruiting
Rome, Italy, 00135
Contact: Adriana Roncella, MD     +090633061     adrianaroncella@hotmail.it    
Sponsors and Collaborators
San Filippo Neri General Hospital
  More Information

No publications provided

Responsible Party: Adriana Roncella, MD, San Filippo Neri Hospital
ClinicalTrials.gov Identifier: NCT00769366     History of Changes
Other Study ID Numbers: 2008
Study First Received: October 7, 2008
Last Updated: October 7, 2008
Health Authority: Italy: Ethics Committee

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 June 18, 2013