Coronary Artery DiseaseCONSERVENCT01810198
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
A study testing Cardiac CT and Invasive Coronary Angiography in people with Coronary Artery Disease, run by MDDX LLC at 13 sites in 6 countries.
Trial summary
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac CT and Invasive Coronary Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,631 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Dec 2012to Mar 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients providing written informed consent
- Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication
Who cannot join
- Known CAD (myocardial infarction, PCI, CABG)
- ACC/AHA Class I or III indication for ICA
- Non-cardiac illness with life expectancy <2 years
- Inability to provide written informed consent
- Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
- Pregnant women
Show all 11Show fewer
- Allergy to iodinated contrast agent
- Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
- Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
- Heart rate ≥100 beats per minute
- 12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
South Korea8 sites
Kangwon National University Hospital
Seoul, South Korea
Ajou University Hospital
Seoul
Gangnam Severance Hospital
Seoul
Gangneung Asan Hospital
Seoul
Korea university, Guro hospital
Seoul
Pusan National University Hospital
Seoul
Severance Hospital
Seoul
Yeongnam University Hospital
Seoul
About this study
Official title: Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
Read the detailed description
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac CT, Invasive Coronary Angiography
- Keywords
- Coronary Artery Disease, Cardiac CT, Catheterization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTProcedure or surgery
Perform a non-invasive Cardiac CT Angiogram
Invasive Coronary AngiographyProcedure or surgery
Patient undergoes Invasive Coronary Angiography
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | Active comparator | Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography) Receives: Procedure: Cardiac CT |
| Invasive Coronary Angiography | Active comparator | Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography Receives: Procedure: Invasive Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE Endpoints
- Death
- Non-fatal myocardial infarction
- Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive)
- Stroke
- Urgent or emergent coronary revascularization
- Cardiovascular hospitalization (including for angina, heart failure or other)
Measured: 1 year
Secondary outcomes (1)
Additional MACE Endpoints
- The primary composite MACE endpoint plus major bleeding.
- The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage.
- The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,631 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDDX LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- James Min, MD, Principal investigator, Cornell Weill Medical CollegeDan Gebow, PhD, Study director, MDDX LLCHyuk-Jae Chang, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810198
- Sponsor's protocol ID
- CONSERVE
- Acronym
- CONSERVE
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.
PubMed 30553687
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
- ClinicalTrials.gov ID
- NCT01810198
- Acronym / sponsor ID
- CONSERVE / CONSERVE
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Cardiac CT, Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,631 participants (actual)
- Lead sponsor
- MDDX LLCIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Mar 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.
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
Detailed description
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | Active comparator | Procedure: Cardiac CTPatients who undergo Cardiac CT (instead of Invasive Coronary Angiography) |
| Invasive Coronary Angiography | Active comparator | Procedure: Invasive Coronary AngiographyPatients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Patients providing written informed consent
- Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication
Key exclusion criteria (11 listed)
- Known CAD (myocardial infarction, PCI, CABG)
- ACC/AHA Class I or III indication for ICA
- Non-cardiac illness with life expectancy <2 years
- Inability to provide written informed consent
- Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
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 CTPerform a non-invasive Cardiac CT Angiogram | Procedure or surgery | Cardiac CT |
| Invasive Coronary AngiographyPatient undergoes Invasive Coronary Angiography | Procedure or surgery | Invasive Coronary Angiography |
Primary outcome
MACE Endpoints
Time frame: 1 year
* Death * Non-fatal myocardial infarction * Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) * Stroke * Urgent or emergent coronary revascularization * Cardiovascular hospitalization (including for angina, heart failure or other)
1 secondary outcome
Additional MACE Endpoints
Time frame: 1 year
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 22 Mar 2017.
- Derived from this study: PubMed 30553687Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.
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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.
James Min, MD principal investigator
Cornell Weill Medical College
Dan Gebow, PhD study director
MDDX LLC
Hyuk-Jae Chang, MD principal investigator
Severance Hospital
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT and Invasive Coronary Angiography in people with Coronary Artery Disease, run by MDDX LLC at 13 sites in 6 countries.
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 3 inclusion and 11 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea, United States, Brazil, India, Italy and 1 more country. 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?
MACE Endpoints (time frame: 1 year). 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 NCT01810198, which also lists 1 linked publication.
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 22 Mar 2017.