Acute Myocardial InfarctionSTEP-IN-AMINCT00769366
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
A study testing Psychotherapy and Medical therapy in people with Acute Myocardial Infarction, run by San Filippo Neri General Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Psychotherapy and Medical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jun 2005to 1 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Psychotherapy, Medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
humanistic-existential psychotherapy conducted in individual and group meetings
Medical therapyDrug
Optimal medical therapy after Acute myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Psychotherapy and medical therapy Receives: Behavioral: Psychotherapy |
| Control | Active comparator | Optimal medical therapy Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
Measured: 5 years
Secondary outcomes (1)
Incidence of re-hospitalisations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study start2 Jun 2005
- Primary completion1 Nov 2011
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Pristipino, San Filippo Neri General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769366
- Sponsor's protocol ID
- 2008
- Acronym
- STEP-IN-AMI
- Status last verified
- Apr 2017
- First submitted
- 7 Oct 2008
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
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 30659815Roncella 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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00769366
- Acronym / sponsor ID
- STEP-IN-AMI / 2008
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Study start
- 2 Jun 2005
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: PsychotherapyPsychotherapy and medical therapy |
| Control | Active comparator | Drug: Medical therapyOptimal medical therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapyhumanistic-existential psychotherapy conducted in individual and group meetings | Behavioural | Psychotherapy |
| Medical therapyOptimal medical therapy after Acute myocardial infarction | Drug | Control |
Primary outcome
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
Time frame: 5 years
1 secondary outcome
Incidence of re-hospitalisations
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 30659815Pristipino 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.
- Derived from this study: PubMed 24239154Roncella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy and Medical therapy in people with Acute Myocardial Infarction, run by San Filippo Neri General Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769366, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.