Cardiac EventNCT01830023
Vitality Trial - Sampling Examination Data
An observational study of Cardiac Event, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Event
- What is being tested?
- cardiac ultrasound examination
- Type of treatment
- Medical device
- How many people
- 2,019 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Dec 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are examined in the department of cardiology, university hospital Aachen
Who may be able to join
- MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent.
Who cannot join
- no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, university hospital
Aacehn, North Rhine Westfalia, 52074
About this study
This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.
- Conditions
- Cardiac Event
- Being tested
- cardiac ultrasound examination
- Keywords
- cardiac ultrasound, vitality, data, patients, examined
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac ultrasound examinationDevice
cardiac ultrasound examination to examine the vitality
| Study group | Role | What they receive |
|---|---|---|
| cardiac ultrasound examination | Not described Receives: Device: cardiac ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitality data
Measured: 1 day (at time of examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMay 2009
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 2,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830023
- Sponsor's protocol ID
- 06-28
- Status last verified
- Sep 2015
- First submitted
- 9 Apr 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitality Trial - Sampling Examination Data
- ClinicalTrials.gov ID
- NCT01830023
- Acronym / sponsor ID
- 06-28
- Conditions
- Cardiac Event
- Keywords
- cardiac ultrasound, vitality, data, patients, examined
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,019 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Apr 2013 (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.
This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac ultrasound examination | – | Device: cardiac ultrasound examination |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are examined in the department of cardiology, university hospital Aachen
Key inclusion criteria (1 listed)
- MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent.
Key exclusion criteria (1 listed)
- no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome
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 |
|---|---|---|
| cardiac ultrasound examinationcardiac ultrasound examination to examine the vitality | Device | cardiac ultrasound examination |
Primary outcome
vitality data
Time frame: 1 day (at time of examination)
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 23 Sep 2015.
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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 Cardiac Event, run by RWTH Aachen University at 1 site in Germany.
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 1 inclusion and 1 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 23 Sep 2015. 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 Germany. 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?
vitality data (time frame: 1 day (at time of examination)). 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 23 Sep 2015.