Myocardial ScarringVIVA 1NCT01408134
Viability Imaging in Volumetric Angiography (VIVA 1)
A study testing DE CT in people with Myocardial Scarring, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The primary objective of this study is twofold: 1. To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging 2. To evaluate DE CT image quality using a consensus DECT protocol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Scarring
- What is being tested?
- DE CT
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Feb 2013
- 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
- Eligible patients will be adults, ages 18 and above with:
- Known CAD with prior MI based upon clinical history or electrocardiographic criteria
- Planned redo-surgical myocardial revascularization
- Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation
Who cannot join
- Inability to provide informed consent
- Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis)
- Chronic kidney disease manifested by a serum creatinine >1.5 mg/dL, an estimated creatinine clearance <50 ml/kg/min or on dialysis
- Currently reporting or evaluated in NYHA class IV heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography
The primary objective of this study is twofold:
- To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging
- To evaluate DE CT image quality using a consensus DECT protocol
Read the detailed description
The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.
- Conditions
- Myocardial Scarring
- Being tested
- DE CT
- Keywords
- Inter-reader variability of myocardial viability imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE CTOther
Delayed scan (per VIVA protocol): The delayed scan will be performed 10 minutes after contrast second contrast bolus complete using axial acquisition at 100 kVp. Scan length will be limited to the cardiac structures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-reader variability of myocardial viability
To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging, specifically:
- Per myocardial segment binary visual estimation of the presence/absence of contrast enhancement on either a first pass or 10-minute delayed CT scan.
- Myocardial enhancement (hyper and hypo-enhancement) will be evaluated using a binary assessment for estimation of the involved myocardial segments on delayed images. Regional wall motion will be assessed qualitatively using a 4 point scale: normal, hypokinetic, akinetic, dyskinetic.
Measured: day One
DE CT image quality
To evaluate DE CT image quality using a consensus DECT protocol
Measured: day One
Secondary outcomes (1)
Scan and patient factors related to the image quality
The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging
Measured: day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2013
Why it stopped: PI/Project director no longer at facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial ScarringStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408134
- Sponsor's protocol ID
- VIVA 1
- Acronym
- VIVA 1
- Status last verified
- Mar 2013
- First submitted
- 28 Jul 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography
- ClinicalTrials.gov ID
- NCT01408134
- Acronym / sponsor ID
- VIVA 1 / VIVA 1
- Conditions
- Myocardial Scarring
- Keywords
- Inter-reader variability of myocardial viability imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI/Project director no longer at facility
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Aug 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 primary objective of this study is twofold:
- To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging
- To evaluate DE CT image quality using a consensus DECT protocol
Detailed description
The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible patients will be adults, ages 18 and above with:
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis)
- Chronic kidney disease manifested by a serum creatinine >1.5 mg/dL, an estimated creatinine clearance <50 ml/kg/min or on dialysis
- Currently reporting or evaluated in NYHA class IV heart failure
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 |
|---|---|---|
| DE CTDelayed scan (per VIVA protocol): The delayed scan will be performed 10 minutes after contrast second contrast bolus complete using axial acquisition at 100 kVp. Scan length will be limited to the cardiac structures. | Other | – |
Primary outcome
Inter-reader variability of myocardial viability
Time frame: day One
To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging, specifically: * Per myocardial segment binary visual estimation of the presence/absence of contrast enhancement on either a first pass or 10-minute delayed CT scan. * Myocardial enhancement (hyper and hypo-enhancement) will be evaluated using a binary assessment for estimation of the involved myocardial segments on delayed images. Regional wall motion will be assessed qualitatively using a 4 point scale: normal, hypokinetic, akinetic, dyskinetic.
DE CT image quality
Time frame: day One
To evaluate DE CT image quality using a consensus DECT protocol
1 secondary outcome
Scan and patient factors related to the image quality
Time frame: day One
Results and safety
The study was stopped early (reason given: PI/Project director no longer at facility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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?
A study testing DE CT in people with Myocardial Scarring, run by Medstar Health Research Institute 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 4 inclusion and 4 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 29 Mar 2013. 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 was stopped early (reason given: PI/Project director no longer at facility). 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?
Inter-reader variability of myocardial viability (time frame: day One). The study lists 2 primary outcomes in all. 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 29 Mar 2013.