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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Psychotherapy
Medical therapy
Sponsored by
San Filippo Neri General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San filippo Neri Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychotherapy

Control

Arm Description

Psychotherapy and medical therapy

Optimal medical therapy

Outcomes

Primary Outcome Measures

The cumulative incidence of new cardiological events and the occurrence of new medical pathologies

Secondary Outcome Measures

Incidence of re-hospitalisations

Full Information

First Posted
October 7, 2008
Last Updated
April 28, 2017
Sponsor
San Filippo Neri General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00769366
Brief Title
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
Acronym
STEP-IN-AMI
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2, 2005 (undefined)
Primary Completion Date
November 1, 2011 (Actual)
Study Completion Date
November 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Filippo Neri General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Psychotherapy and medical therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Optimal medical therapy
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
humanistic-existential psychotherapy conducted in individual and group meetings
Intervention Type
Drug
Intervention Name(s)
Medical therapy
Intervention Description
Optimal medical therapy after Acute myocardial infarction
Primary Outcome Measure Information:
Title
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Incidence of re-hospitalisations
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
San filippo Neri Hospital
City
Rome
ZIP/Postal Code
00135
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30659815
Citation
Pristipino C, Roncella A, Pasceri V, Speciale G. Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results. Am J Med. 2019 May;132(5):639-646.e5. doi: 10.1016/j.amjmed.2018.12.025. Epub 2019 Jan 17.
Results Reference
derived
PubMed Identifier
24239154
Citation
Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.
Results Reference
derived

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Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction

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