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Completed

NCT Number: NCT00769366

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San filippo Neri Hospital

Rome, 00135, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Behavioral

humanistic-existential psychotherapy conducted in individual and group meetings

Medical Therapy

Drug

Optimal medical therapy after Acute myocardial infarction

Primary outcomes

  1. The cumulative incidence of new cardiological events and the occurrence of new medical pathologies

    Time frame: 5 years

Secondary outcomes

  1. Incidence of re-hospitalisations

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

San Filippo Neri General Hospital

Other

Registry information

Official study title

Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)

Acronym: STEP-IN-AMI

Important dates

Study start
2005
Primary completion
2011
Study completion
2016
First posted
Oct 9, 2008
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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