Congestive Heart FailureNCT00273819
Study of Coronary Artery Disease by Two Types of Angiography
A study testing CT angiography in people with Congestive Heart Failure, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- CT angiography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2007
- 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
- Congestive heart failure with EF<40%
- Age> 18 years
Who cannot join
- Contrast allergy
- Renal insufficiency
- Inability or unwillingness to sign a consent
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
VACT Healthcare System-Yale School of Medicine
West Haven, Connecticut, 06516
About this study
Official title: Non-Invasive Detection of Revascularizable Cardiomyopathy
The purpose of this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.
Read the detailed description
Objective:
In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. With the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. The goal of this study is to compare non-invasive computed tomography (CT) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. Revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex).
Research Design:
This study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography.
Methods:
Subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. Exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). We would like to enroll 30 patients. After giving informed consent, all eligible patients will undergo CT angiography, performed using new multi-slice technology. The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.
- Conditions
- Congestive Heart Failure
- Being tested
- CT angiography
- Keywords
- Congestive heart failure, LV dysfunction
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of coronary disease by CT angiography
Secondary outcomes (1)
Disease meets latest ACC/AHA guidelines for CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startOct 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Investigators
- Aseem Vashist, M.D., Principal investigator, VACHS and Yale University School of MedicineMehran Sadeghi, M.D., Principal investigator, VACHS and Yale University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273819
- Sponsor's protocol ID
- AS0006
- Other IDs
- 00795
- Status last verified
- Jan 2009
- First submitted
- 5 Jan 2006
- Last updated
- 27 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Detection of Revascularizable Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00273819
- Acronym / sponsor ID
- AS0006
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive heart failure, LV dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Oct 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Jan 2006 (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 this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.
Detailed description
Objective:
In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. With the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. The goal of this study is to compare non-invasive computed tomography (CT) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. Revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex).
Research Design:
This study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography.
Methods:
Subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. Exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). We would like to enroll 30 patients. After giving informed consent, all eligible patients will undergo CT angiography, performed using new multi-slice technology. The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Congestive heart failure with EF<40%
- Age> 18 years
Key exclusion criteria (4 listed)
- Contrast allergy
- Renal insufficiency
- Inability or unwillingness to sign a consent
- Diabetes Mellitus
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 |
|---|---|---|
| CT angiography | Procedure or surgery | – |
Primary outcome
Detection of coronary disease by CT angiography
1 secondary outcome
Disease meets latest ACC/AHA guidelines for CABG
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 27 Jan 2009.
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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.
Aseem Vashist, M.D. principal investigator
VACHS and Yale University School of Medicine
Mehran Sadeghi, M.D. principal investigator
VACHS and Yale University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT angiography in people with Congestive Heart Failure, run by VA Connecticut Healthcare System 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 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: finished, as of the sponsor's last update on 27 Jan 2009. 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?
Detection of coronary disease by CT angiography. 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 27 Jan 2009.