Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
STEP-IN-AMI
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMay 2, 2017
April 1, 2017
6.4 years
October 7, 2008
April 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
5 years
Secondary Outcomes (1)
Incidence of re-hospitalisations
5 years
Study Arms (2)
Psychotherapy
EXPERIMENTALPsychotherapy and medical therapy
Control
ACTIVE COMPARATOROptimal medical therapy
Interventions
humanistic-existential psychotherapy conducted in individual and group meetings
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San filippo Neri Hospital
Rome, 00135, Italy
Related Publications (2)
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.
PMID: 30659815DERIVEDRoncella 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.
PMID: 24239154DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Head of Research and Training section, Interventional Cardiology Unit
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 9, 2008
Study Start
June 2, 2005
Primary Completion
November 1, 2011
Study Completion
November 1, 2016
Last Updated
May 2, 2017
Record last verified: 2017-04