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

San Filippo Neri General Hospital

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Drug: Medical therapy; Behavioral: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00769366

2008

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Psychotherapy

Experimental group

Description:

Psychotherapy and medical therapy

Treatment:

Behavioral: Psychotherapy

Control

Active Comparator group

Description:

Optimal medical therapy

Treatment:

Drug: Medical therapy