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NCT Number: NCT04576130

A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation

DanICD is a randomized, controlled study to with the aim to assess whether there is a benefit of ICD-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an LVEF above 35%.

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Key information

Conditions

Coronary Artery Disease Acute Myocardial Infarction Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Cardiac Conduction System Disease Cardiovascular Diseases Coronary Disease Heart Arrest Heart Diseases Myocardial Ischemia Out-Of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Vascular Diseases Ventricular Fibrillation Ventricular Tachycardia, Sustained

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Location contact

Reza Jabbari, MD, PhD

CONTACT

[email protected]

+4535455380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CAD and cardiac arrest due to VF/VT, where angiogram is performed with complete revascularization (PCI, CABG or hybrid coronary revascularization) before ICD implantation. Unfavorable artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization.
  • Age ≥18 years
  • LVEF >35% at the time of discharge. The most recent LVEF assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline LVEF.

Exclusion criteria

  • Non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy)
  • Previous CABG within the last 3 months before index hospitalization
  • Life expectancy less than 1 year or severe neurologic outcome
  • Unable or unwilling to give informed consent
  • Pregnancy

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

Implantation of an ICD for secondary prevention

Other names: ICD

Primary outcomes

  1. All-cause mortality

    Time frame: 5 years

    The clinical event committee will aim to attribute the cause of death to the underlying disease process rather than the immediate mechanism. Mortality will be classified as cardiovascular and non-cardiovascular.

Secondary outcomes

  1. All cause mortality

    Time frame: 1 year

  2. Sudden cardiovascular death

    Time frame: 1 year

    Cardiovascular death fulfilling the following criteria:

    • In witnessed cases a change in cardiovascular status with time until death being <1 hour.
    • In unwitnessed cases <24 hours since last seen alive and functioning normal.

  3. Cardiovascular death

    Time frame: 1 year

    Mortality is considered as cardiovascular unless it is clearly attributable to another cause and thus includes:

    • Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure).
    • Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
    • All procedure-related deaths, including those related to a complication of the ICD-procedure or treatment for a complication of the procedure.
    • All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events.
    • Death of unknown or cardiac cause.

Other outcomes

  1. Device revision or replacement due to infection or malfunction

    Time frame: 1 year

    Explorative outcome

  2. Appropriate shock from an ICD (successfully treated VT/VF)

    Time frame: 1 year

    Explorative outcome

  3. Inappropriate shock from an ICD (shock on non-VT/VF)

    Time frame: 1 year

    Explorative outcome

  4. Register-based all cause mortality

    Time frame: 10 years

  5. Register-based sudden cardiovascular death

    Time frame: 5 years

  6. Register-based sudden cardiovascular death

    Time frame: 10 years

  7. Register-based cardiovascular death

    Time frame: 5 years

  8. Register-based cardiovascular death

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Reza Jabbari, MD, PhD

CONTACT

[email protected]

+4535455380

Thomas Engstrøm, MD, PhD, DMSc

CONTACT

[email protected]

+4535458444

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

A Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation Who Receive Complete Revascularization

Acronym: DanICD

Important dates

Study start
2020
Primary completion
2032
Study completion
2032
First posted
Oct 6, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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