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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Behavioral: Psychotherapy; Drug: Medical therapy

• Registration Number: NCT00769366
• Lead Sponsor: San Filippo Neri General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-02
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-09
• Primary Completion: 2011-11-01
• Study Completion: 2016-11-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychotherapy	Psychotherapy	Psychotherapy and medical therapy
Control	Medical therapy	Optimal medical therapy

Primary Outcome Measures

Name	Time	Method
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies	5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of re-hospitalisations	5 years

Trial Locations

Locations (1)

San filippo Neri Hospital; 🇮🇹 Rome, Italy