BRING-UP Prevention

Recruiting

• Conditions: Ischemic Heart Disease; Cerebrovascular Disorders; Peripheral Arterial Disease

• Registration Number: NCT06275113
• Lead Sponsor: Heart Care Foundation

Brief Summary

The aim of this observational study is to assess in patients with a documented athero-thrombotic event: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD):

* the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels.

* the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence.

Detailed Description

Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers.

Phases:

1. First educational intervention to discuss the recommendations of guidelines for secondary prevention strategies.

2. Data collection for 3 months or up to 30 consecutive patients in patients with documented CAD/CVD/PAD on a web Case Record Form (CRF) generating warning on the most relevant guideline recommendations, and, when guidelines are not followed, asking the reason for non-adherence.

3. Evaluation of the primary and secondary end-points of the study at 6 months after enrollment.

4. Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice.

5. New data collection for 3 months or up to 30 consecutive patients in patients with documented CAD/CVD/PAD on a web CRF generating warning on the most relevant guideline recommendations, and, when guidelines are not followed, asking the reason for non-adherence.

6. Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment.

7. 12-month follow-up for all patients included in both enrolment phases.

Study Timeline

• Study Start: 2023-09-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Both sexes at birth, age ≥18 years

At least one of the following clinical conditions:

• Documented CAD defined as:

  • Prior Acute Coronary Syndrom (ACS)
  • Prior Coronary Artery Bypass Graft (CABG)
  • Prior Percutaneous Coronary Intervention (PCI)

• Documented PAD (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease, Ankle Brachial Index (ABI)<90).

• Documented CVD: Ischemic stroke, previous carotid vascular interventions.

• Signed informed consent.

Exclusion Criteria

• Active neoplasia or very severe disease compromising short-medium term life expectancy.
• Participation in interventional studies.
• Patients already enrolled into the study from another participating center or in the previous enrolling phase.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to guideline for cholesterol level	6 months	Rate of patients at goal for LDL cholesterol (\<55 mg/dL)

Secondary Outcome Measures

Name	Time	Method
Adherence to guideline for other risk factors	6 months	Rate of patients at goal for BP (SBP/DBP \< 130/80 mmHg) and at goal for HbA1c (\<7%) as well as rate of overweight patients (BMI \> 27 kg/m2) who show a weight loss of at least 10%

Trial Locations

Locations (195)

Ospedale Barone Lombardo - Cardiologia E Utic; 🇮🇹 Canicatti', AG, Italy

Ospedale San Giacomo D'Altopasso - Uoc Cardiologia; 🇮🇹 Licata, AG, Italy

Ospedale Santo Spirito - Sc Cardiologia; 🇮🇹 Casale Monferrato, AL, Italy

Ospedale San Giacomo - Sc Cardiologia; 🇮🇹 Novi Ligure, AL, Italy

Ospedali Riuniti - Clinica Di Cardiologia E Aritmologia; 🇮🇹 Ancona, AN, Italy

Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic; 🇮🇹 Ancona, AN, Italy

Casa Di Cura Villa Serena - U.O. Cardiologia Riabilitativa; 🇮🇹 Jesi, AN, Italy

Ospedale Madonna Del Soccorso - Uoc Cardiologia Indirizzo Riabilitativo; 🇮🇹 San Benedetto Del Tronto, AP, Italy

Ospedale San Donato - U.O.C Cardiologia; 🇮🇹 Arezzo, AR, Italy

Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona; 🇮🇹 Cortona, AR, Italy

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