Acute Myocardial InfarctionPSYCHONICNCT03437642
Psyhosomatic Medicine in Oncologic and Cardiac Disease Study
An observational study of Acute Myocardial Infarction and Tako Tsubo Cardiomyopathy, run by San Filippo Neri General Hospital at 1 site in Italy.
Trial summary
Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Tako Tsubo Cardiomyopathy, Breast Cancer
- What is being tested?
- Short Term Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2018to Dec 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 50 patients ≤ 75 year old with acute myocardial infarction; * 30 patients ≤ 75 year old with Tako-Tsubo syndrome; * 50 women ≤ 75 year old, recently operated on breast cancer: * 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.
Who may be able to join
- Patients within one week from an Acute myocardial infarction treated with primary or urgent PCI
- Patients within one week from the onset of Tako Tsubo cardiomyopathy.
- Patients with a diagnosis of breast cancer in the preceding six months
- Age and sex matched control subjects without relevant medical pathologies in the preceding 10 years
Who cannot join
- Cognitive impairment
- Refusing the enrolment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Filippo Neri General Hospital
Roma, 00135
Adriana Roncella, MD, 0633062504, adriana.roncella@aslroma1.it
About this study
Official title: Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics
Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated.
The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases .
Read more
The patients that will be enrolled are:
- 50 patients ≤ 75 year old with acute myocardial infarction;
- 30 patients ≤ 75 year old with Tako-Tsubo syndrome;
- 50 women ≤ 75 year old, recently operated on breast cancer:
- 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.
At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2).
In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered.
The same evaluation will be done for the healthy subjects.
After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.
At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered.
The following data will be evaluated:
Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life
At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.
- Being tested
- Short Term Psychotherapy
- Medical subject headings
- Takotsubo Cardiomyopathy, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Term PsychotherapyBehavioural
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
| Study group | Role | What they receive |
|---|---|---|
| Tako-Tsubo - STP | Short term psychotherapy + Classic cardiological therapy Receives: Behavioral: Short Term Psychotherapy | |
| Tako-Tsubo - Control | Classic cardiological therapy only | |
| Oncologic - STP | Short term psychotherapy + Classic oncological therapy Receives: Behavioral: Short Term Psychotherapy | |
| Oncologic - Control | Classic oncological therapy only | |
| AMI - STP | Short term psychotherapy + Classic cardiological therapy Receives: Behavioral: Short Term Psychotherapy | |
| AMI - Control | Classic cardiological therapy only | |
| Healthy Subjects | No therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of new relevant medical events
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
Measured: at 1 year
Secondary outcomes (16)
Cumulative incidence of new relevant medical events
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
Measured: at 5 years
Changes in body perception and dreams
These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions.
Measured: at 1 year
Incidence of rehospitalisations
Number of rehospitalisations during the first year of follow-up
Measured: at 1 year
Incidence of rehospitalisations
Number of rehospitalisations during 5 years follow-up
Measured: at 5 years
Distress grade
Self-evaluation test (score range 1-10, higher stress for higher values)
Measured: at 1 year
Distress grade
Self-evaluation test (score range 1-10, higher stress for higher values)
Measured: at 5 years
Depression symptoms
Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)
Measured: at 1 year
Depression symptoms
Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)
Measured: at 5 years
Social support
Social support questionnaire (score range 12-72, the higher the score the lower the support)
Measured: at 1 year
Social support
Social support questionnaire (score range 12-72, the higher the score the lower the support)
Measured: at 5 year
Quality of life
Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged)
Measured: at 1 year
Quality of life
Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged)
Measured: at 5 years
Anxiety grade
State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)
Measured: At 1 year
Anxiety grade
State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)
Measured: At 5 years
Anger level
State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)
Measured: at 1 year
Anger level
State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start27 Mar 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 220 participants (estimated)
- Target duration
- 5 Years
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
- Investigators
- Adriana Roncella, MD, Principal investigator, San Filippo Neri General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437642
- Sponsor's protocol ID
- v24-9-2017
- Acronym
- PSYCHONIC
- Status last verified
- Sep 2019
- First submitted
- 22 Dec 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roncella A, Pristipino C, Di Carlo O, Ansuini M, Corbosiero A, Di Fusco SA, Palumbo G, Gigantesco A, Mirabella F, De Angelis R, Pasceri V, Cancellara L, Colivicchi F, Allan R, Mirri MA, Speciale G. PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol. J Clin Med. 2021 Dec 10;10(24):5786. doi: 10.3390/jcm10245786.
PubMed 34945081
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics
- ClinicalTrials.gov ID
- NCT03437642
- Acronym / sponsor ID
- PSYCHONIC / v24-9-2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated.
The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases .
The patients that will be enrolled are:
- 50 patients ≤ 75 year old with acute myocardial infarction;
- 30 patients ≤ 75 year old with Tako-Tsubo syndrome;
- 50 women ≤ 75 year old, recently operated on breast cancer:
- 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.
At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2).
In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered.
The same evaluation will be done for the healthy subjects.
After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.
At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered.
The following data will be evaluated:
Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life
At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Tako-Tsubo - STP | – | Behavioral: Short Term PsychotherapyShort term psychotherapy + Classic cardiological therapy |
| Tako-Tsubo - Control | – | –Classic cardiological therapy only |
| Oncologic - STP | – | Behavioral: Short Term PsychotherapyShort term psychotherapy + Classic oncological therapy |
| Oncologic - Control | – | –Classic oncological therapy only |
| AMI - STP | – | Behavioral: Short Term PsychotherapyShort term psychotherapy + Classic cardiological therapy |
| AMI - Control | – | –Classic cardiological therapy only |
| Healthy Subjects | – | –No therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 50 patients ≤ 75 year old with acute myocardial infarction; * 30 patients ≤ 75 year old with Tako-Tsubo syndrome; * 50 women ≤ 75 year old, recently operated on breast cancer: * 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.
Key inclusion criteria (4 listed)
- Patients within one week from an Acute myocardial infarction treated with primary or urgent PCI
- Patients within one week from the onset of Tako Tsubo cardiomyopathy.
- Patients with a diagnosis of breast cancer in the preceding six months
- Age and sex matched control subjects without relevant medical pathologies in the preceding 10 years
Key exclusion criteria (2 listed)
- Cognitive impairment
- Refusing the enrolment
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 |
|---|---|---|
| Short Term PsychotherapyHumanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs | Behavioural | AMI - STP, Oncologic - STP, Tako-Tsubo - STP |
Primary outcome
Cumulative incidence of new relevant medical events
Time frame: at 1 year
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
16 secondary outcomes
Cumulative incidence of new relevant medical events
Time frame: at 5 years
Changes in body perception and dreams
Time frame: at 1 year
Incidence of rehospitalisations
Time frame: at 1 year
Incidence of rehospitalisations
Time frame: at 5 years
Distress grade
Time frame: at 1 year
Distress grade
Time frame: at 5 years
Depression symptoms
Time frame: at 1 year
Depression symptoms
Time frame: at 5 years
Social support
Time frame: at 1 year
Social support
Time frame: at 5 year
Quality of life
Time frame: at 1 year
Quality of life
Time frame: at 5 years
Anxiety grade
Time frame: At 1 year
Anxiety grade
Time frame: At 5 years
Anger level
Time frame: at 1 year
Anger level
Time frame: at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 34945081Roncella A, Pristipino C, Di Carlo O, Ansuini M, Corbosiero A, Di Fusco SA, Palumbo G, Gigantesco A, Mirabella F, De Angelis R, Pasceri V, Cancellara L, Colivicchi F, Allan R, Mirri MA, Speciale G. PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol. J Clin Med. 2021 Dec 10;10(24):5786. doi: 10.3390/jcm10245786.
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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.
Adriana Roncella, MD principal investigator
San Filippo Neri General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Tako Tsubo Cardiomyopathy, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana Roncella, MD (+39060633062504, adrianaroncella@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of new relevant medical events (time frame: at 1 year). 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 NCT03437642, which also lists 1 linked publication.
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 18 Sep 2019.