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

April 28, 2017 updated by: Christian Pristipino, San Filippo Neri General Hospital

Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00135
        • San Filippo Neri Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of re-hospitalisations
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Filippo Neri General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 2, 2005

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008 (U.S. NIH Grant/Contract: Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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