NCT05764109Completed
Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation
AdhereNce to Cied Implantation GuidELInes: Cardiac rehAbilitation as a Window on Time-dependent Indications: an Observational Prospective Study (ANGELICA).
Source: ClinicalTrials.gov · Last updated 29 Jan 2025
Brief summary (registry, in English)
There are limited data on how the guideline indications for ICD implantation are applied in clinical practice across Europe. Moreover, the impact of "time-dependence" of some indications to implantation on the guidelines adherence is still unknown. Objective of the present observational study is the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to ICD/CRT-D implantation admitted to an in-hospital cardiac rehabilitation program.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 488 (actual)
- First submitted
- 1 Mar 2023
- Start date
- 15 Sept 2019
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Coronary artery disease
- NCT number
- NCT05764109
What you commit to
- Study type: Observational
- Participants enrolled: 488
- From 15 Sept 2019 to the primary completion date, 29 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- NYHA Class I or IV during the cardiac rehabilitation in-hospital stay;
Lab values
- LVEF \> 40% at echocardiography performed at the admittance in the cardiac rehabilitation facility
Age
- Age \< 18 years;
Other
- Inability to give informed consent (diminished understanding or comprehension);
- Absence of a time-dependent indication to an ICD/CRT-D implantation;
- Indication to ICD-CRT-D implantation for secondary prevention.
Who the study is looking for
- Admission to an in-hospital cardiac rehabilitation program because of a recent index event;
- Provision of signed and dated informed consent form;
- Age ≥ 18 years.
- NYHA II-III class at the admittance in the cardiac rehabilitation facility;
- LVEF ≤ 40% at echocardiography at the admittance in the cardiac rehabilitation facility;
- Presence of a time-dependent indication to an ICD/CRT-D implantation:
- \<3 month of optimal medical therapy;
- \<40 days from the index myocardial infarction in patients with acute coronary syndrome;
- 3 months from the revascularization procedure in patients with surgery;
- \<3 months in patients with a de-novo heart failure episode of no ischemic etiology.
- Patients who have already received an ICD/CRT-D for primary prevention before the admittance in the cardiac rehabilitation facility, despite a time-dependent indication to an ICD/CRT-D implantation;
- Indication to ICD-CRT-D implantation for primary prevention.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICS Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.