Acute Coronary SyndromeCTDATABASENCT00922662
Database of Patients Undergoing Cardiac Computed Tomographic Angiography at William Beaumont Hospital (CT DATABASE)
An observational study of Acute Coronary Syndrome and Chest Pain, run by Kavitha Chinnaiyan at 1 site in United States.
Trial summary
The purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Both genders * Retrospective CCTA subjects who have undergone CCTA in the past 5 years at this institution * Prospective subjects who will have a CCTA at this institution (ongoing)
Who may be able to join
- all retrospective patients who under went a CTA and were granted a waiver of consent
- all prospective patients CTA patients who gave informed consent.
Who cannot join
- Non CTA patients
- Patients who refused participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Health System - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Database of Patients Undergoing Cardiac Computed Tomographic Angiography (CCTA)at William Beaumont Hospital
The purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific reasons.
Read the detailed description
The principal goal of his project is to enable the study investigators to organize WBH research activity in the field of CCTA by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. It will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Keywords
- coronary artery disease, chest pain, CCTA
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all WBH patients undergoing CCTA testing for clinical or scientific reasons.
Measured: annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Cohort
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kavitha Chinnaiyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kavitha Chinnaiyan, Corewell Health East
- Investigators
- Kavitha Chinnaiyan, MD, Principal investigator, William Beaumont Hospital-Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922662
- Sponsor's protocol ID
- 2009-021
- Acronym
- CTDATABASE
- Status last verified
- Sep 2016
- First submitted
- 15 Jun 2009
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database of Patients Undergoing Cardiac Computed Tomographic Angiography (CCTA)at William Beaumont Hospital
- ClinicalTrials.gov ID
- NCT00922662
- Acronym / sponsor ID
- CTDATABASE / 2009-021
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Keywords
- coronary artery disease, chest pain, CCTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Kavitha ChinnaiyanUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jun 2009 (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 purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific reasons.
Detailed description
The principal goal of his project is to enable the study investigators to organize WBH research activity in the field of CCTA by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. It will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.
Study design
- Observational model
- Cohort
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Both genders * Retrospective CCTA subjects who have undergone CCTA in the past 5 years at this institution * Prospective subjects who will have a CCTA at this institution (ongoing)
Key inclusion criteria (2 listed)
- all retrospective patients who under went a CTA and were granted a waiver of consent
- all prospective patients CTA patients who gave informed consent.
Key exclusion criteria (2 listed)
- Non CTA patients
- Patients who refused participation.
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
To establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all WBH patients undergoing CCTA testing for clinical or scientific reasons.
Time frame: annually for 5 years
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 14 Sep 2016.
- 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.
Kavitha Chinnaiyan, MD principal investigator
William Beaumont Hospital-Royal Oak
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 Acute Coronary Syndrome and Chest Pain, run by Kavitha Chinnaiyan at 1 site in United States.
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 2 inclusion and 2 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 14 Sep 2016. 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 United States. 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?
To establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all WBH patients undergoing CCTA testing for clinical or scientific reasons. (time frame: annually for 5 years). 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 14 Sep 2016.