Coronary Artery DiseaseVERDICT-EDINCT02061891
Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes
A study testing Invasive coronary evaluation (Deferred) and Invasive coronary evaluation (Acute) in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred, subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation myocardial infarction (NSTEMI) Acute coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Invasive coronary evaluation (Deferred) and Invasive coronary evaluation (Acute)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with clinical suspicion of of UAP/NSTEMI acute coronary syndrome deemed suitable for invasive evaluation and treatment will be included in the study.
- Age> 18 years
- At least one of the following:
- ECG abnormalities suggestive of myocardial ischemia (newly developed ST segment depression, horizontal or descending >= 0,05mV in two anatomically adjacent leads and/or T-wave inversion >0,01 mV in two leads with prominent R wave or R/S ratio >1
- Elevated myocardial ischemia biomarkers (Troponin, CK-MB)
Who cannot join
- Pregnancy
- Circumstances preventing the patient from reading and/or understanding the research protocol information
- Clinical indication for acute invasive coronary angiography - severe chest pain despite intravenous nitroglycerin infusion or hemodynamic instability
- Expected survival of less than 1 year
- Known allergy/hypersensitivity of pharmacological platelet inhibitors and/or iodine contrast that cannot be prevented medically
- Patients with known eGFR below 60 ml/min will not undergo CCTA, whereas patients in dialysis will undergo the entire study protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Entire Danish Initiative To ImrpOve Revascularization Strategies (EDITORS) - A Randomised Evaluation of Clinical Outcome After Acute or Deferred Invasive Intervention Integrated With MDCT Imaging in Patients With Acute Coronary Syndromes
The aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred, subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational design the potential clinical benefit of coronary computed tomography angiography (CCTA) to select patients for invasive investigation and treatment in the two treatment arms (acute vs deferred) is evaluated.
The following main hypothesis will be tested:
- Very early invasive coronary investigation improves clinical outcome in patients with UAP/NSTEMI-ACS
- CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS
Read the detailed description
MATERIAL Consecutive patients suspected of UAP/NSTEMI will be screened for participation in the study. Only patients deemed clinically suited for invasive coronary evaluation and treatment will be included. A total of 2500 patients will be included in the trial at Departments of Cardiology of Danish Hospitals.
METHODS If the patients accept participation in the trial a computerized 1:1 randomization for acute invasive coronary evaluation (Intervention group - within 12 hours from time of diagnosis) or for deferred invasive evaluation (Control group - no later than 72 hours from time of diagnosis). All included patients undergo CCTA prior to invasive coronary evaluation, except for patient with moderately reduced renal function (se below). The treating invasive cardiologist will remain blinded to observational CCTA data. Patients with endstage renal disease in dialysis may undergo CCTA. CCTA data recorded as part of the research protocol will not be made available for the treating physician.
SECONDARY EXCLUSION Based on post-hoc expert clinical evaluation patients not having UAP/NSTEMI-ACS (arrythmias, pulmonary oedema, missed STEMI, pneumonia, Pulmonary emboli) will be excluded from analysis of difference between outcome measures in treatment strategy groups.
STATISTICAL METHODS Patients with UAP/NSTEMI-ACS are based on previous studies expected to have an event rate of 15% within 1 year and 50% at 4 years of the primary combined endpoint: all cause mortality, non-fatal recurrent myocardial infarction, hospitalisation for refractory ischemia or heart failure. In order to demonstrate a reduction of 25% within 3 years 711 patients in each group are needed. The study is powered to detect a clinical relevant reduction in mortality or heart failure hospitalization with a total of 2500 patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Invasive coronary evaluation (Deferred), Invasive coronary evaluation (Acute)
- Keywords
- Coronary Stenosis, Coronary Artery Disease, Acute coronary syndrome, Percutaneous Coronary Intervention, Multidetector Computed Tomography
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary evaluation (Deferred)Procedure or surgery
Invasive coronary angiography and revascularization (PCI/CABG)
Invasive coronary evaluation (Acute)Procedure or surgery
Invasive coronary angiography and revascularization (PCI/CABG)
| Study group | Role | What they receive |
|---|---|---|
| Deferred invasive evaluation | Active comparator | Deferred invasive coronary evaluation and revascularization (PCI/CABG) within 72 hours from time of clinical diagnosis (CONTROL group) Receives: Procedure: Invasive coronary evaluation (Deferred) |
| Very early invasive evaluation | Experimental | Acute invasive coronary evaluation within 12 hours from time of diagnosis - INTERVENTION group Receives: Procedure: Invasive coronary evaluation (Acute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite clinical endpoint
Composite endpoint of all cause mortality, non-fatal recurrent acute myocardial infarction, hospitalisation for refractory ischemia (acute coronary syndrome) or heart failure
Measured: 3 years
Secondary outcomes (8)
Bleeding
Major and minor bleeding according to TIMI and BARC classification systems
Measured: During index hospitalization - an expected average of 5 days
Non-bleeding, invasive procedure related complications
Invasive procedure related acute myocardial infarction, embolic stroke, cardiac arrest
Measured: During index hospitalization - an expected average of 5 days
Death
All-cause death
Measured: 3 and 5 years
Non-fatal acute myocardial infarction
Measured: 3 and 5 years
Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)
Measured: 3 and 5 years
Repeat coronary revascularization
Recorded from 30 days post-index procedure
Measured: 3 and 5 years
Hospital admittance due to left ventricular heart failure
Measured: 3 and 5 years
GRACE Risk Score
All primary and secondary endpoints stratified by GRACE score at a threshold of 140
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startNov 2010
- Primary completionJun 2016
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars V Køber, MD, DmSc, Study chair, Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061891
- Sponsor's protocol ID
- H-4-2010-039
- Other IDs
- EDITORS
- Acronym
- VERDICT-EDI
- Status last verified
- Dec 2022
- First submitted
- 6 Feb 2014
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Navarese EP, Gurbel PA, Andreotti F, Tantry U, Jeong YH, Kozinski M, Engstrom T, Di Pasquale G, Kochman W, Ardissino D, Kedhi E, Stone GW, Kubica J. Optimal timing of coronary invasive strategy in non-ST-segment elevation acute coronary syndromes: a systematic review and meta-analysis. Ann Intern Med. 2013 Feb 19;158(4):261-70. doi: 10.7326/0003-4819-158-4-201302190-00006.
PubMed 23420234Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986.
PubMed 19458363Kristensen TS, Kofoed KF, Kuhl JT, Nielsen WB, Nielsen MB, Kelbaek H. Prognostic implications of nonobstructive coronary plaques in patients with non-ST-segment elevation myocardial infarction: a multidetector computed tomography study. J Am Coll Cardiol. 2011 Jul 26;58(5):502-9. doi: 10.1016/j.jacc.2011.01.058.
PubMed 21777748Ratcovich H, Sadjadieh G, Linde JJ, Joshi FR, Kelbaek H, Kofoed KF, Kober L, Hansen PR, Torp-Pedersen C, Elming H, Gislason GH, Hofsten DE, Engstrom T, Holmvang L. Coronary CT and timing of invasive coronary angiography in patients >/=75 years old with non-ST segment elevation acute coronary syndromes. Heart. 2023 Feb 23;109(6):457-463. doi: 10.1136/heartjnl-2022-321640.
PubMed 36351794Butt JH, Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Holmvang L, Pedersen F, Bang LE, Sigvardsen PE, Clemmensen P, Linde JJ, Heitmann M, Hove JD, Abdulla J, Gislason G, Engstrom T, Kober L. Importance of Risk Assessment in Timing of Invasive Coronary Evaluation and Treatment of Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome: Insights From the VERDICT Trial. J Am Heart Assoc. 2021 Oct 5;10(19):e022333. doi: 10.1161/JAHA.121.022333. Epub 2021 Sep 29.
PubMed 34585591Kofoed KF, Engstrom T, Sigvardsen PE, Linde JJ, Torp-Pedersen C, de Knegt M, Hansen PR, Fritz-Hansen T, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Dominguez Vall-Lamora MH, Kragelund C, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Gislason G, Kelbaek H, Kober LV. Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 2;77(8):1044-1052. doi: 10.1016/j.jacc.2020.12.037.
PubMed 33632478Linde JJ, Kelbaek H, Hansen TF, Sigvardsen PE, Torp-Pedersen C, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Vall-Lamora MHD, Kragelund C, de Knegt M, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Hansen PR, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Engstrom T, Gislason G, Kober LV, Kofoed KF. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Feb 11;75(5):453-463. doi: 10.1016/j.jacc.2019.12.012.
PubMed 32029126Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Klovgaard L, Holmvang L, Helqvist S, Jorgensen E, Galatius S, Pedersen F, Bang L, Saunamaki K, Clemmensen P, Linde JJ, Heitmann M, Wendelboe Nielsen O, Raymond IE, Kristiansen OP, Svendsen IH, Bech J, Dominguez Vall-Lamora MH, Kragelund C, Hansen TF, Dahlgaard Hove J, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Abildgaard U, Jensen JS, Gislason G, Kober LV, Engstrom T. Early Versus Standard Care Invasive Examination and Treatment of Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. Circulation. 2018 Dec 11;138(24):2741-2750. doi: 10.1161/CIRCULATIONAHA.118.037152.
PubMed 30565996
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entire Danish Initiative To ImrpOve Revascularization Strategies (EDITORS) - A Randomised Evaluation of Clinical Outcome After Acute or Deferred Invasive Intervention Integrated With MDCT Imaging in Patients With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT02061891
- Acronym / sponsor ID
- VERDICT-EDI / H-4-2010-039
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Stenosis, Coronary Artery Disease, Acute coronary syndrome, Percutaneous Coronary Intervention, Multidetector Computed Tomography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Nov 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2030 (estimated)
- First posted
- 13 Feb 2014 (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 aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred, subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational design the potential clinical benefit of coronary computed tomography angiography (CCTA) to select patients for invasive investigation and treatment in the two treatment arms (acute vs deferred) is evaluated.
The following main hypothesis will be tested:
- Very early invasive coronary investigation improves clinical outcome in patients with UAP/NSTEMI-ACS
- CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS
Detailed description
MATERIAL Consecutive patients suspected of UAP/NSTEMI will be screened for participation in the study. Only patients deemed clinically suited for invasive coronary evaluation and treatment will be included. A total of 2500 patients will be included in the trial at Departments of Cardiology of Danish Hospitals.
METHODS If the patients accept participation in the trial a computerized 1:1 randomization for acute invasive coronary evaluation (Intervention group - within 12 hours from time of diagnosis) or for deferred invasive evaluation (Control group - no later than 72 hours from time of diagnosis). All included patients undergo CCTA prior to invasive coronary evaluation, except for patient with moderately reduced renal function (se below). The treating invasive cardiologist will remain blinded to observational CCTA data. Patients with endstage renal disease in dialysis may undergo CCTA. CCTA data recorded as part of the research protocol will not be made available for the treating physician.
SECONDARY EXCLUSION Based on post-hoc expert clinical evaluation patients not having UAP/NSTEMI-ACS (arrythmias, pulmonary oedema, missed STEMI, pneumonia, Pulmonary emboli) will be excluded from analysis of difference between outcome measures in treatment strategy groups.
STATISTICAL METHODS Patients with UAP/NSTEMI-ACS are based on previous studies expected to have an event rate of 15% within 1 year and 50% at 4 years of the primary combined endpoint: all cause mortality, non-fatal recurrent myocardial infarction, hospitalisation for refractory ischemia or heart failure. In order to demonstrate a reduction of 25% within 3 years 711 patients in each group are needed. The study is powered to detect a clinical relevant reduction in mortality or heart failure hospitalization with a total of 2500 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred invasive evaluation | Active comparator | Procedure: Invasive coronary evaluation (Deferred)Deferred invasive coronary evaluation and revascularization (PCI/CABG) within 72 hours from time of clinical diagnosis (CONTROL group) |
| Very early invasive evaluation | Experimental | Procedure: Invasive coronary evaluation (Acute)Acute invasive coronary evaluation within 12 hours from time of diagnosis - INTERVENTION group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinical suspicion of of UAP/NSTEMI acute coronary syndrome deemed suitable for invasive evaluation and treatment will be included in the study.
- Age> 18 years
- At least one of the following:
- ECG abnormalities suggestive of myocardial ischemia (newly developed ST segment depression, horizontal or descending >= 0,05mV in two anatomically adjacent leads and/or T-wave inversion >0,01 mV in two leads with prominent R wave or R/S ratio >1
- Elevated myocardial ischemia biomarkers (Troponin, CK-MB)
Key exclusion criteria (6 listed)
- Pregnancy
- Circumstances preventing the patient from reading and/or understanding the research protocol information
- Clinical indication for acute invasive coronary angiography - severe chest pain despite intravenous nitroglycerin infusion or hemodynamic instability
- Expected survival of less than 1 year
- Known allergy/hypersensitivity of pharmacological platelet inhibitors and/or iodine contrast that cannot be prevented medically
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 |
|---|---|---|
| Invasive coronary evaluation (Deferred)Invasive coronary angiography and revascularization (PCI/CABG) | Procedure or surgery | Deferred invasive evaluation |
| Invasive coronary evaluation (Acute)Invasive coronary angiography and revascularization (PCI/CABG) | Procedure or surgery | Very early invasive evaluation |
Primary outcome
Composite clinical endpoint
Time frame: 3 years
Composite endpoint of all cause mortality, non-fatal recurrent acute myocardial infarction, hospitalisation for refractory ischemia (acute coronary syndrome) or heart failure
8 secondary outcomes
Bleeding
Time frame: During index hospitalization - an expected average of 5 days
Non-bleeding, invasive procedure related complications
Time frame: During index hospitalization - an expected average of 5 days
Death
Time frame: 3 and 5 years
Non-fatal acute myocardial infarction
Time frame: 3 and 5 years
Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)
Time frame: 3 and 5 years
Repeat coronary revascularization
Time frame: 3 and 5 years
Hospital admittance due to left ventricular heart failure
Time frame: 3 and 5 years
GRACE Risk Score
Time frame: 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 23420234Navarese EP, Gurbel PA, Andreotti F, Tantry U, Jeong YH, Kozinski M, Engstrom T, Di Pasquale G, Kochman W, Ardissino D, Kedhi E, Stone GW, Kubica J. Optimal timing of coronary invasive strategy in non-ST-segment elevation acute coronary syndromes: a systematic review and meta-analysis. Ann Intern Med. 2013 Feb 19;158(4):261-70. doi: 10.7326/0003-4819-158-4-201302190-00006.
- Background: PubMed 19458363Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986.
- Background: PubMed 21777748Kristensen TS, Kofoed KF, Kuhl JT, Nielsen WB, Nielsen MB, Kelbaek H. Prognostic implications of nonobstructive coronary plaques in patients with non-ST-segment elevation myocardial infarction: a multidetector computed tomography study. J Am Coll Cardiol. 2011 Jul 26;58(5):502-9. doi: 10.1016/j.jacc.2011.01.058.
- Derived from this study: PubMed 36351794Ratcovich H, Sadjadieh G, Linde JJ, Joshi FR, Kelbaek H, Kofoed KF, Kober L, Hansen PR, Torp-Pedersen C, Elming H, Gislason GH, Hofsten DE, Engstrom T, Holmvang L. Coronary CT and timing of invasive coronary angiography in patients >/=75 years old with non-ST segment elevation acute coronary syndromes. Heart. 2023 Feb 23;109(6):457-463. doi: 10.1136/heartjnl-2022-321640.
- Derived from this study: PubMed 34585591Butt JH, Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Holmvang L, Pedersen F, Bang LE, Sigvardsen PE, Clemmensen P, Linde JJ, Heitmann M, Hove JD, Abdulla J, Gislason G, Engstrom T, Kober L. Importance of Risk Assessment in Timing of Invasive Coronary Evaluation and Treatment of Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome: Insights From the VERDICT Trial. J Am Heart Assoc. 2021 Oct 5;10(19):e022333. doi: 10.1161/JAHA.121.022333. Epub 2021 Sep 29.
- Derived from this study: PubMed 33632478Kofoed KF, Engstrom T, Sigvardsen PE, Linde JJ, Torp-Pedersen C, de Knegt M, Hansen PR, Fritz-Hansen T, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Dominguez Vall-Lamora MH, Kragelund C, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Gislason G, Kelbaek H, Kober LV. Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 2;77(8):1044-1052. doi: 10.1016/j.jacc.2020.12.037.
- Derived from this study: PubMed 32029126Linde JJ, Kelbaek H, Hansen TF, Sigvardsen PE, Torp-Pedersen C, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Vall-Lamora MHD, Kragelund C, de Knegt M, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Hansen PR, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Engstrom T, Gislason G, Kober LV, Kofoed KF. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Feb 11;75(5):453-463. doi: 10.1016/j.jacc.2019.12.012.
- Derived from this study: PubMed 30565996Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Klovgaard L, Holmvang L, Helqvist S, Jorgensen E, Galatius S, Pedersen F, Bang L, Saunamaki K, Clemmensen P, Linde JJ, Heitmann M, Wendelboe Nielsen O, Raymond IE, Kristiansen OP, Svendsen IH, Bech J, Dominguez Vall-Lamora MH, Kragelund C, Hansen TF, Dahlgaard Hove J, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Abildgaard U, Jensen JS, Gislason G, Kober LV, Engstrom T. Early Versus Standard Care Invasive Examination and Treatment of Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. Circulation. 2018 Dec 11;138(24):2741-2750. doi: 10.1161/CIRCULATIONAHA.118.037152.
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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.
Lars V Køber, MD, DmSc study chair
Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive coronary evaluation (Deferred) and Invasive coronary evaluation (Acute) in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2022. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite clinical endpoint (time frame: 3 years). 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 NCT02061891, which also lists 8 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 12 Dec 2022.