ClinicalTrials.gg
CompletedNCT00769366STEP-IN-AMIUpdated May 2, 2017

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

An interventional study of Psychotherapy and Medical therapy in Acute Myocardial Infarction, sponsored by San Filippo Neri General Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-02.

Sponsored by San Filippo Neri General Hospital · Not applicable, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 140 studies in Myocardial Infarction with a site in Italy — 14 open to participants now, 25 under way, 6 of them phase 3. Myocardial Infarction · Italy.

Enrollment
80th of 101
101 · median 432
Started
2005
with 5 others
No phase
22 of 140
4 open now
Registered
30th of 140
by date

Among the 140 studies in Myocardial Infarction with a site in Italy, this one is the 80th largest by enrollment of the 101 interventional ones that give a count, is one of 6 that started in 2005, is one of 22 with no phase, and was the 30th registered.

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

Browse Myocardial Infarction studies →

Open to participants now

14 of the 140 studies in Myocardial Infarction with a site in Italy are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 140 studies in Myocardial Infarction with a site in Italy, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Acute Myocardial Infarction
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Psychotherapy

    Psychotherapy and medical therapy

    Behavioral: Psychotherapy

  • Active comparator
    Control

    Optimal medical therapy

    Drug: Medical therapy

Interventions

  • BehavioralPsychotherapy

    humanistic-existential psychotherapy conducted in individual and group meetings

  • DrugMedical therapy

    Optimal medical therapy after Acute myocardial infarction

06

What researchers measure

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

07

Study locations

1 site
  • San filippo Neri Hospital
    Rome, 00135, Italy
08

References and documents

Publications

  • 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. PubMed 30659815 ↗
  • 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. PubMed 24239154 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of Nov 2011 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2008
First posted
Oct 9, 2008
Start
Jun 2, 2005
Primary completionActual
Nov 1, 2011
CompletionActual
Nov 1, 2016
Last update
May 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00769366
Lead sponsor
San Filippo Neri General Hospital
Responsible party
Christian Pristipino (MD, Head of Research and Training section, Interventional Cardiology Unit, San Filippo Neri General Hospital) — Principal investigator
First posted
Oct 9, 2008
Start date
Jun 2, 2005
Primary completion
Nov 1, 2011
Completion
Nov 1, 2016
Last update
May 2, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion