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

Acute Myocardial Infarction Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769366
• Other study ID #: 2008
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: April 28, 2017
• Start date: June 2, 2005
• Est. completion date: November 1, 2016

Study information

• Verified date: April 2017
• Source: San Filippo Neri General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Psychotherapy
humanistic-existential psychotherapy conducted in individual and group meetings

Drug:
• Medical therapy
Optimal medical therapy after Acute myocardial infarction

Locations

Country	Name	City	State
Italy	San filippo Neri Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative incidence of new cardiological events and the occurrence of new medical pathologies		5 years
Secondary	Incidence of re-hospitalisations		5 years