Cardiovascular Prevention Supported by Digital Technology... | NCT07608926

Studies
Cardiovascular Prevention Supported by Digital Technology: Comparison With the Traditional Model

NCT07608926

Sponsor

Maria Cecilia Hospital

Status

Recruiting

Last Update Posted

May 27, 2026Actual

Enrollment

144Estimated

Phase

Not Applicable

Conditions

Cardiovascular (CV) Risk

Interventions

Recommendations to the patient.

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2025Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Apr 28, 2026

First Submission Date that Met QC Criteria

May 19, 2026

First Posted Date

May 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiovascular diseases represent one of the leading causes of morbidity and mortality worldwide. Prevention in patients at cardiovascular risk is essential to reduce the incidence of cardiovascular events and slow the progression of risk.

This study aims to evaluate the effectiveness and feasibility of a cardiovascular prevention pathway delivered remotely through a digital application, comparing it with a traditional in-person care pathway.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Digital technology	Experimental	Remote management of study participants, enabling the structured collection of relevant information for follow-up.	Other: Recommendations to the patient.
on site	Other	adherence to in-person follow-up at the hospital.	Other: Recommendations to the patient.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recommendations to the patient.	Other	Recommendations to the patient	Digital technology on site

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Systolic and diastolic in millimeters of mercury	12 months
number of cigarettes		24 months

Secondary Outcomes

Measure	Description	Time Frame
body weigh		24 months
number of daily steps		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 40 and 75 years
hypertension
hyperglycaemia
type 2 diabetes not requiring insulin therapy
dyslipidaemia
active smoking
overweight/grade I obesity
Willingness to participate in follow-up visits over 24 months

Exclusion Criteria:

previous myocardial infarction
stroke
transient ischemic attack
coronary artery diseas
peripheral arterial occlusive disease
heart failure
Type 1 or type 2 diabetes mellitus on insulin therapy
Advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
Active cancer disease
Severe obesity
Inability to use digital tools
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maria Cecilia Hospital	Recruiting	Cotignola	Ravenna	48033	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided