Randomized, Controlled Study on Short-term Psychotherapy... | NCT00769366

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

NCT00769366

Sponsor

San Filippo Neri General Hospital

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

101Actual

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Psychotherapy
Medical therapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2005

Primary Completion Date

Nov 1, 2011Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2017

Last Update Posted Date

May 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Pristipino, MD, Head of Research and Training section, Interventional Cardiology Unit, San Filippo Neri General HospitalPrincipal Investigator

Lead Sponsor

San Filippo Neri General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychotherapy	Experimental	Psychotherapy and medical therapy	Behavioral: Psychotherapy
Control	Active Comparator	Optimal medical therapy	Drug: Medical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy	Behavioral	humanistic-existential psychotherapy conducted in individual and group meetings	Psychotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies		5 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of re-hospitalisations		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San filippo Neri Hospital		Rome		00135	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30659815	Derived	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.
24239154	Derived	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.

ID	Term
D011613	Psychotherapy
D044623	Nutrition Therapy

ID	Term
D004191	Behavioral Disciplines and Activities
D013812	Therapeutics