Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation

NCT05764109 | Completed

• 1 other identifier: CE 2296
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Left Ventricular Systolic Dysfunction; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

ICS Maugeri

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Myocardial Infarction

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 10, 2023
• Study Start: September 15, 2019
• Primary Completion: December 29, 2023
• Study Completion: January 28, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)