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

NCT ID: NCT00769366

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-02

Study Completion Date

2016-11-01

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psychotherapy

Psychotherapy and medical therapy

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

humanistic-existential psychotherapy conducted in individual and group meetings

Control

Optimal medical therapy

Group Type ACTIVE_COMPARATOR

Medical therapy

Intervention Type DRUG

Optimal medical therapy after Acute myocardial infarction

Interventions

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Psychotherapy

humanistic-existential psychotherapy conducted in individual and group meetings

Intervention Type BEHAVIORAL

Medical therapy

Optimal medical therapy after Acute myocardial infarction

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Filippo Neri General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Pristipino

MD, Head of Research and Training section, Interventional Cardiology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San filippo Neri Hospital

Rome, , Italy

Site Status

Countries

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Italy

References

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Pristipino C, Roncella A, Pasceri V, Speciale G. Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results. Am J Med. 2019 May;132(5):639-646.e5. doi: 10.1016/j.amjmed.2018.12.025. Epub 2019 Jan 17.

Reference Type DERIVED
PMID: 30659815 (View on PubMed)

Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.

Reference Type DERIVED
PMID: 24239154 (View on PubMed)

Other Identifiers

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2008

Identifier Type: -

Identifier Source: org_study_id

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