Post-COVID ConditionsNCT05758649
Cardiovascular and Psychological Consequences of COVID-19
An observational study of Post-COVID Conditions, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-COVID Conditions
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 29 Feb 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who will refer to the disease clinics 2-3 months after discharge from the COVID-19 areas of ICS Maugeri.
Who may be able to join
- Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease
Who cannot join
- Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
- Non-Italian education, illiteracy, or return to illiteracy.
- Severe visual-perceptual deficits.
- Low motivation/interest or refusal to undergo the assessment.
Trial locations and contacts
1 site in 1 country.
About this study
The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.
Read the detailed description
A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.
Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.
The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.
A second follow-up visit will be performed at 12 months in the form of structured interview,
- Conditions
- Post-COVID Conditions
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of patients with cardiovascular or psychological sequelae
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Oct 2020
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
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 Post-COVID ConditionsStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758649
- Sponsor's protocol ID
- CE 2450
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vigore M, Steccanella A, Maffoni M, Torlaschi V, Gorini A, La Rovere MT, Maestri R, Bussotti M, Masnaghetti S, Fanfulla F, Pierobon A. Patients' Clinical and Psychological Status in Different COVID-19 Waves in Italy: A Quanti-Qualitative Study. Healthcare (Basel). 2023 Sep 6;11(18):2477. doi: 10.3390/healthcare11182477.
PubMed 37761674
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Psychological Consequences of COVID-19
- ClinicalTrials.gov ID
- NCT05758649
- Acronym / sponsor ID
- CE 2450
- Conditions
- Post-COVID Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 7 Mar 2023 (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.
The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.
Detailed description
A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.
Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.
The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.
A second follow-up visit will be performed at 12 months in the form of structured interview,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will refer to the disease clinics 2-3 months after discharge from the COVID-19 areas of ICS Maugeri.
Key inclusion criteria (1 listed)
- Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease
Key exclusion criteria (4 listed)
- Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
- Non-Italian education, illiteracy, or return to illiteracy.
- Severe visual-perceptual deficits.
- Low motivation/interest or refusal to undergo the assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of patients with cardiovascular or psychological sequelae
Time frame: 3 months
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 6 Mar 2024.
- Results publication: PubMed 37761674Vigore M, Steccanella A, Maffoni M, Torlaschi V, Gorini A, La Rovere MT, Maestri R, Bussotti M, Masnaghetti S, Fanfulla F, Pierobon A. Patients' Clinical and Psychological Status in Different COVID-19 Waves in Italy: A Quanti-Qualitative Study. Healthcare (Basel). 2023 Sep 6;11(18):2477. doi: 10.3390/healthcare11182477.
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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?
An observational study of Post-COVID Conditions, run by Istituti Clinici Scientifici Maugeri SpA 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 1 inclusion and 4 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 6 Mar 2024. 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?
prevalence of patients with cardiovascular or psychological sequelae (time frame: 3 months). 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 NCT05758649, 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 6 Mar 2024.