Coronary Artery DiseaseFARGONCT02477371
Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
A study testing Fractional flow reserve-guided CABG and Angiography-guided CABG in people with Coronary Artery Disease and Coronary Disease, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- What is being tested?
- Fractional flow reserve-guided CABG and Angiography-guided CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesDenmark
- Study dates
- Jun 2014to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
- At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
- Signed informed consent form
Who cannot join
- Significant valvular disease with indication to surgical treatment
- Previous open-heart-surgery
- Left main lesion without other intermediate lesions
- Treatment with Persantin Retard
- One vessel disease
- Renal impairment (creatinine ≥ 150 umol / l)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital
Aalborg, 9100
Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus
Aarhus, Aarhus N, 8200
Anne Langhoff Thuesen
Odense, Odense C, 5000
About this study
The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.
Read the detailed description
FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Cardiovascular Diseases
- Being tested
- Fractional flow reserve-guided CABG, Angiography-guided CABG
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserve-guided CABGProcedure or surgery
Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values > 0,8 are deferred.
Angiography-guided CABGProcedure or surgery
Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting.
| Study group | Role | What they receive |
|---|---|---|
| Fractional flow reserve-guided CABG | Experimental | Patients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR > 0,8 are deferred. Receives: Procedure: Fractional flow reserve-guided CABG |
| Angiography-guided CABG | Active comparator | Patients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography. Receives: Procedure: Angiography-guided CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage open grafts of all grafts
Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)
Measured: 6 months
Secondary outcomes (6)
Graft stenosis (shaft and anastomoses)
Measured: 6 months
Change in CCS class from index to follow-up (FU)
CCS class (Canadian Cardiovascular Society grading of angina)
Measured: 6 months
Change in Quality of life (EQ-5D) from index to FU
Measured: 6 months
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
Measured: 6 months
Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.
Measured: The first 24 hours after the operation
Procedure time
Measured: During surgery (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Langhoff Thuesen, Odense University Hospital
- Investigators
- Anne Langhoff Thuesen, MD, Principal investigator, Department of Cardio-thoracic surgery, Odense University HospitalLisette Okkels Jensen, MD,PhD,DMSc, Study director, Department of Cardiology, Odense University HospitalPer Thayssen, MD, DMSc, Study chair, Department of Cardiology, Odense University HospitalPoul Erik Mortensen, MD, Study chair, Department of Cardio-thoracic surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477371
- Sponsor's protocol ID
- S-20130050
- Acronym
- FARGO
- Status last verified
- Oct 2018
- First submitted
- 19 Jan 2015
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Borregaard B, Junker A, Mortensen PE, Jensen LO. Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e007302. doi: 10.1161/CIRCOUTCOMES.120.007302. Epub 2021 Jun 3.
PubMed 34078097Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.
PubMed 30497559
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
- ClinicalTrials.gov ID
- NCT02477371
- Acronym / sponsor ID
- FARGO / S-20130050
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2015 (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 FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.
Detailed description
FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional flow reserve-guided CABG | Experimental | Procedure: Fractional flow reserve-guided CABGPatients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR > 0,8 are deferred. |
| Angiography-guided CABG | Active comparator | Procedure: Angiography-guided CABGPatients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
- At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
- Signed informed consent form
Key exclusion criteria (6 listed)
- Significant valvular disease with indication to surgical treatment
- Previous open-heart-surgery
- Left main lesion without other intermediate lesions
- Treatment with Persantin Retard
- One vessel disease
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 |
|---|---|---|
| Fractional flow reserve-guided CABGCoronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values > 0,8 are deferred. | Procedure or surgery | Fractional flow reserve-guided CABG |
| Angiography-guided CABGCoronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting. | Procedure or surgery | Angiography-guided CABG |
Primary outcome
Percentage open grafts of all grafts
Time frame: 6 months
Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)
6 secondary outcomes
Graft stenosis (shaft and anastomoses)
Time frame: 6 months
Change in CCS class from index to follow-up (FU)
Time frame: 6 months
Change in Quality of life (EQ-5D) from index to FU
Time frame: 6 months
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
Time frame: 6 months
Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.
Time frame: The first 24 hours after the operation
Procedure time
Time frame: During surgery (minutes)
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 18 Oct 2018.
- Derived from this study: PubMed 34078097Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Borregaard B, Junker A, Mortensen PE, Jensen LO. Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e007302. doi: 10.1161/CIRCOUTCOMES.120.007302. Epub 2021 Jun 3.
- Derived from this study: PubMed 30497559Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
Anne Langhoff Thuesen, MD principal investigator
Department of Cardio-thoracic surgery, Odense University Hospital
Lisette Okkels Jensen, MD,PhD,DMSc study director
Department of Cardiology, Odense University Hospital
Per Thayssen, MD, DMSc study chair
Department of Cardiology, Odense University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional flow reserve-guided CABG and Angiography-guided CABG in people with Coronary Artery Disease and Coronary Disease, run by Odense University Hospital at 3 sites in Denmark.
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 6 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Percentage open grafts of all grafts (time frame: 6 months). 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 NCT02477371, which also lists 2 linked publications.
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 18 Oct 2018.