Randomized, Controlled Study on Short-Term Psychotherapy After Acute Myocardial Infarction - Full Text View

Sponsored by:	San Filippo Neri General Hospital
Information provided by:	San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:	NCT00769366

Purpose

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.

Condition	Intervention
Acute Myocardial Infarction	Behavioral: Psychotherapy Drug: Medical therapy

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:

The cumulative incidence of new cardiological events and the occurrence of new medical pathologies [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of re-hospitalisations [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	May 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Psychotherapy: Experimental Psychotherapy and medical therapy	Behavioral: Psychotherapy humanistic-existential psychotherapy conducted in individual and group meetings
Control: Active Comparator Optimal medical therapy	Drug: Medical therapy Optimal medical therapy after Acute myocardial infarction

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769366

Contacts

Contact: Adriana Roncella, MD

+390633061

adrianaroncella@hotmail.it

Locations

Italy
San filippo Neri Hospital	Recruiting
Rome, Italy, 00135
Contact: Adriana Roncella, MD +090633061 adrianaroncella@hotmail.it

Sponsors and Collaborators

San Filippo Neri General Hospital

More Information

Responsible Party:	San Filippo Neri Hospital ( Adriana Roncella, MD )
Study ID Numbers:	2008
Study First Received:	October 7, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00769366
Health Authority:	Italy: Ethics Committee

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009