Left Ventricular Systolic DysfunctionANGELICANCT05764109
Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation
An observational study of Left Ventricular Systolic Dysfunction and Myocardial Infarction, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Left Ventricular Systolic Dysfunction, Myocardial Infarction
- How many people
- 488 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2019to 28 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be those with LVEF <40% of both ischemic and non-ischemic etiology, NYHA class II-III, who, at the discharge from the hospital, do not show as satisfied the temporal windows suggested by the guidelines as useful for a conclusive LVEF evaluation: <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.
Who may be able to join
- 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:
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- <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.
Who cannot join
- Inability to give informed consent (diminished understanding or comprehension);
- Age < 18 years;
- NYHA Class I or IV during the cardiac rehabilitation in-hospital stay;
- LVEF > 40% at echocardiography performed at the admittance in the cardiac rehabilitation facility
- Absence of a time-dependent indication to an ICD/CRT-D implantation;
- Indication to ICD-CRT-D implantation for secondary prevention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AdhereNce to Cied Implantation GuidELInes: Cardiac rehAbilitation as a Window on Time-dependent Indications: an Observational Prospective Study (ANGELICA).
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.
Read the detailed description
Current guidelines recommend ICD implantation in patients at high risk of sudden cardiac death with either ischemic or non-ischemic heart disease. However, implantation rate of cardiac implantable electrical devices (CIED), especially ICD, CRT and CRT-D, is lower than expected and do not reflect guideline indications.
Several factors may justify the differences in ICD implantation rates across Europe and the gap between daily clinical practice and guidelines: economic restrictions, poor guidelines awareness, especially among referring cardiologists and general practitioners, and different guidelines adherence. The impact of "time-dependence" of some indications to CIED implantation on the guidelines adherence is still unknown.
Objective of the present observational study will be 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.
This is a prospective, multicenter, observational study performed in 6 cardiac rehabilitation facilities.
- Medical subject headings
- Ventricular Dysfunction, Left, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of LVEF assessment
The evaluation of the rate of patients who will perform an echocardiography for LVEF assessment at the end of the time-window as suggested by the guidelines
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Sep 2019
- Primary completion29 Dec 2023
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Systolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764109
- Sponsor's protocol ID
- CE 2296
- Acronym
- ANGELICA
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdhereNce to Cied Implantation GuidELInes: Cardiac rehAbilitation as a Window on Time-dependent Indications: an Observational Prospective Study (ANGELICA).
- ClinicalTrials.gov ID
- NCT05764109
- Acronym / sponsor ID
- ANGELICA / CE 2296
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current guidelines recommend ICD implantation in patients at high risk of sudden cardiac death with either ischemic or non-ischemic heart disease. However, implantation rate of cardiac implantable electrical devices (CIED), especially ICD, CRT and CRT-D, is lower than expected and do not reflect guideline indications.
Several factors may justify the differences in ICD implantation rates across Europe and the gap between daily clinical practice and guidelines: economic restrictions, poor guidelines awareness, especially among referring cardiologists and general practitioners, and different guidelines adherence. The impact of "time-dependence" of some indications to CIED implantation on the guidelines adherence is still unknown.
Objective of the present observational study will be 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.
This is a prospective, multicenter, observational study performed in 6 cardiac rehabilitation facilities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be those with LVEF <40% of both ischemic and non-ischemic etiology, NYHA class II-III, who, at the discharge from the hospital, do not show as satisfied the temporal windows suggested by the guidelines as useful for a conclusive LVEF evaluation: <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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (6 listed)
- Inability to give informed consent (diminished understanding or comprehension);
- Age < 18 years;
- NYHA Class I or IV during the cardiac rehabilitation in-hospital stay;
- LVEF > 40% at echocardiography performed at the admittance in the cardiac rehabilitation facility
- Absence of a time-dependent indication to an ICD/CRT-D implantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of LVEF assessment
Time frame: 3 months
The evaluation of the rate of patients who will perform an echocardiography for LVEF assessment at the end of the time-window as suggested by the guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Systolic Dysfunction and Myocardial Infarction, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of LVEF assessment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.