Extra-hospital Sudden DeathNCT01321918

Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)

A study of Extra-hospital Sudden Death, run by Nantes University Hospital at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extra-hospital Sudden Death
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteFrance
Study dates: Jun 2007to Nov 2010
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults ≥ 18 years of age.
Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
Patients not hospitalized at the time of sudden death.
Case subjects :
Adults ≥ 18 years of age.
Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.

Show all 11Show fewer

Patients not hospitalized at the time of sudden death.
Patients supported clinically by an emergency ambulance service.
Control subjects :
Adults ≥ 18 years of age.
Adults hospitalized in an cardiac intensive care unit.

Who cannot join

Violent death : criminal, suicidal or accidental.
Case subjects :
Violent death : criminal, suicidal or accidental.
Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.
In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :
Adult subject to legal protection measure,

Show all 16Show fewer

Pregnant woman,
Parturient,
Breastfeeding mother,
Person deprived of liberty,
Person hospitalised without his consent,
Person admitted to a medical or socially facility.
Control subjects :
History of sudden death,
Documented history of ventricular fibrillation,
History of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.

Trial locations and contacts

1 site in 1 country.

France1 site

Nantes University Hospital
Nantes, 44093

Other trials in France

About this study

Official title: Register and DNA Bank of Adult Extra-hospital Sudden Death

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.

Conditions: Extra-hospital Sudden Death
Being tested: Case Controls, Control subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Case ControlsOther
A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.
Control subjectsOther
A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.

Study groups in NCT01321918
Study group	Role	What they receive
Case subjects	Other	Not described Receives: Other: Case Controls
Control subjects	Other	Not described Receives: Other: Control subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

Identification of variants in DNA
The primary endpoint is the identification of variants (polymorphisms and / or mutations) in DNA significantly associated with risk of extra-hospital sudden death in adults. Study populations are : (i) the entire population of case subjects included in the DNA bank (ii) two subpopulations at high risk of sudden death : patients with a history of myocardial infarction and patients with LVEF < 30 %. The variable analyzed is the nucleotide sequence of DNA in populations of case and control subjects.

Secondary outcomes (3)

Annual incidence of extra-hospital sudden death in adults
The annual incidence of extra-hospital sudden death in adults. The variable analyzed is the number of incident cases per year of extra-hospital sudden death in adults.
Annual mortality related to extra-hospital sudden death in adults
The annual mortality related to extra-hospital sudden death in adults. The variable analyzed is the number of annual deaths due to sudden death in adults.
Characterization of victims of extra-hospital sudden death in adults
The characterization of victims of extra-hospital sudden death in adults, their medical care in emergency and their future from D0 to D28. Variables analyzed are clinical data are collected in case report forms.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Nov 2010

First posted24 Mar 2011 (estimated)
Study startJun 2007
Primary completionNov 2010
Study completionNov 2010

Why it stopped: Recruitment difficulties

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extra-hospital Sudden DeathStudies of the same condition, open and under way.
More trials run by Nantes University HospitalThe 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: Interventional
Phase: Phase N/A
Masking: None (open label)
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01321918
Sponsor's protocol ID: 06/6-A
Other IDs: 2006-A00544-47
Status last verified: Mar 2011
First submitted: 23 Mar 2011
Last updated: 24 Mar 2011
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Register and DNA Bank of Adult Extra-hospital Sudden Death
ClinicalTrials.gov ID: NCT01321918
Acronym / sponsor ID: 06/6-A
Conditions: Extra-hospital Sudden Death
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment difficulties
Enrolment: 2,000 participants (estimated)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Study start: Jun 2007
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 24 Mar 2011 (estimated)
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.

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.

Study design

Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Case subjects	Other	Other: Case Controls
Control subjects	Other	Other: Control subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Adults ≥ 18 years of age.
Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
Patients not hospitalized at the time of sudden death.
Case subjects :
Adults ≥ 18 years of age.

Key exclusion criteria (16 listed)

Violent death : criminal, suicidal or accidental.
Case subjects :
Violent death : criminal, suicidal or accidental.
Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.
In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Case ControlsA blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.	Other	Case subjects
Control subjectsA blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.	Other	Control subjects

Primary outcome

Identification of variants in DNA
The primary endpoint is the identification of variants (polymorphisms and / or mutations) in DNA significantly associated with risk of extra-hospital sudden death in adults. Study populations are : (i) the entire population of case subjects included in the DNA bank (ii) two subpopulations at high risk of sudden death : patients with a history of myocardial infarction and patients with LVEF < 30 %. The variable analyzed is the nucleotide sequence of DNA in populations of case and control subjects.

3 secondary outcomes

Annual incidence of extra-hospital sudden death in adults
Annual mortality related to extra-hospital sudden death in adults
Characterization of victims of extra-hospital sudden death in adults

Results and safety

The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.

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.

Vincent PROBST, Profesor principal investigator

Nantes University Hospital

Jean-Luc CHASSEVENT, Doctor study chair

University Hospital, Angers

Nicolas HOURDIN, Doctor study chair

CH de Châteaubriant

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Extra-hospital Sudden Death, run by Nantes University Hospital at 1 site in France.

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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 Mar 2011. 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 France. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

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?

Identification of variants in DNA. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321918.

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 24 Mar 2011.