Cardiovascular PreventionNCT06362538
The Cardiovascular Prevention Program
A study testing International Physical Activity Questionnaire, Six minute walking test and SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. in people with Cardiovascular Prevention, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cardiovascular Prevention
- What is being tested?
- International Physical Activity Questionnaire, Six minute walking test and SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2024to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary prevention: age ≥ 30 years with a negative history of cardiovascular events
- secondary prevention: age ≥ 30 years with a negative history of cardiovascular events
Who cannot join
- severe obesity
- high-grade renal failure
- severe and/or dialysis
- oncological disease in active phase
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
MCH
Cotignola, Ravenna, 48033
Anna Maria Malagoni
About this study
Official title: Cardiovascular Prevention Program at Maria Cecilia Hospital
Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.
- Conditions
- Cardiovascular Prevention
- Being tested
- International Physical Activity Questionnaire, Six minute walking test, SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21., MEDAS, Intima-media thickness (IMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Physical Activity QuestionnaireOther
Assessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility
Six minute walking testOther
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.Other
Evaluation of the quality of life, the psychological sphere (anxiety, stress, depression) and the quality of sleep
MEDASOther
Evaluation of adherence to the Mediterranean diet
Intima-media thickness (IMT)Other
Bmode ultrasonography
Blood samplingBiological
Measurement of parameters for defining cardiovascular risk and biomarkers.
Stool Sample Culture TestBiological
Evaluation of Gut Microbiota
| Study group | Role | What they receive |
|---|---|---|
| subject with a negative or positive history of cardiovascular disease | Other | no drugs or devices are included. Receives: Other: International Physical Activity Questionnaire; Other: Six minute walking test; Other: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.; Other: MEDAS; Other: Intima-media thickness (IMT); Biological: Blood sampling; Biological: Stool Sample Culture Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of body mass index
BMI Assessment
Measured: 12 months
Adherence to the Mediterranean diet
Mediterranean Diet Adherence
Measured: 12 months
blood test to check cholesterol levels
Assessment of hypercholesterolemia
Measured: 12 months
blood pressure measurement
Evaluation of Diastolic Blood Pressure
Measured: 12 months
blood glucose test
evaluation of blood glucose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start13 May 2024
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular PreventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Maria Malagoni, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362538
- Sponsor's protocol ID
- MCH-ProCardioPrev
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Prevention Program at Maria Cecilia Hospital
- ClinicalTrials.gov ID
- NCT06362538
- Acronym / sponsor ID
- MCH-ProCardioPrev
- Conditions
- Cardiovascular Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 12 Apr 2024 (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.
Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subject with a negative or positive history of cardiovascular disease | Other | Other: International Physical Activity Questionnaire, Other: Six minute walking test, Other: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21., Other: MEDAS, Other: Intima-media thickness (IMT), Biological: Blood sampling, Biological: Stool Sample Culture Testno drugs or devices are included. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary prevention: age ≥ 30 years with a negative history of cardiovascular events
- secondary prevention: age ≥ 30 years with a negative history of cardiovascular events
Key exclusion criteria (5 listed)
- severe obesity
- high-grade renal failure
- severe and/or dialysis
- oncological disease in active phase
- pregnancy
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 |
|---|---|---|
| International Physical Activity QuestionnaireAssessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility | Other | subject with a negative or positive history of cardiovascular disease |
| Six minute walking testThe 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Other | subject with a negative or positive history of cardiovascular disease |
| SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.Evaluation of the quality of life, the psychological sphere (anxiety, stress, depression) and the quality of sleep | Other | subject with a negative or positive history of cardiovascular disease |
| MEDASEvaluation of adherence to the Mediterranean diet | Other | subject with a negative or positive history of cardiovascular disease |
| Intima-media thickness (IMT)Bmode ultrasonography | Other | subject with a negative or positive history of cardiovascular disease |
| Blood samplingMeasurement of parameters for defining cardiovascular risk and biomarkers. | Biological | subject with a negative or positive history of cardiovascular disease |
| Stool Sample Culture TestEvaluation of Gut Microbiota | Biological | subject with a negative or positive history of cardiovascular disease |
Primary outcome
measure of body mass index
Time frame: 12 months
BMI Assessment
Adherence to the Mediterranean diet
Time frame: 12 months
Mediterranean Diet Adherence
blood test to check cholesterol levels
Time frame: 12 months
Assessment of hypercholesterolemia
blood pressure measurement
Time frame: 12 months
Evaluation of Diastolic Blood Pressure
blood glucose test
Time frame: 12 months
evaluation of blood glucose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Anna Maria Malagoni principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing International Physical Activity Questionnaire, Six minute walking test and SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. in people with Cardiovascular Prevention, run by Maria Cecilia 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Tenti (0545217031 ext. +39, etenti@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of body mass index (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.