Cerebrovascular Disorders, Ischemic Heart Disease, Peripheral Arterial Disease
Conditions
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.
Interventions
None listed
Sponsors
Heart Care Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to guideline for cholesterol level | 6 months | Rate of patients at goal for LDL cholesterol (\<55 mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients' outcome | 12 months | Rate of occurrence of clinical events (all-cause deaths, recurrent athero-thrombotic events, all cause hospitalizations, specific causes of death and hospitalizations) during the 12 follow-up of each enrolment phase. |
Countries
Italy
Contacts
Primary ContactFurio Colivicchi, MD
Backup ContactAldo P Maggioni, MD
Outcome results
None listed