BRING-UP Prevention

Heart Care Foundation

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06275113

K25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.