Cardiac ArrestCOUPENCT02641626
Coronariography in OUt of hosPital Cardiac arrEst
A study testing Urgent Coronary Angiography and Deferred Coronary Angiography in people with Cardiac Arrest, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited. Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Urgent Coronary Angiography and Deferred Coronary Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to 31 Jan 2021
- 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
None listed.
Who cannot join
- Age <18 years.
- Pregnant women or women of childbearing age unless they have a negative pregnancy test.
- Time to return of spontaneous circulation longer than 60 minutes.
- Non-cardiac etiology of the comatose state: drug overdose, head injury or stroke.
- Acute myocardial infarction with ST segment elevation or left bundle branch block, because in those patients emergent angiography is mandatory.
- Hemodynamic instability (refractory cardiogenic shock despite vasoactive drugs or refractory arrhythmias), because in those patients an emergent angiography is mandatory.
- Known coagulopathy or bleeding.
- Refusal to participate in the study by the next of kin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.
Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited. Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.
Read the detailed description
Prospective, multicenter and randomized clinical trial. Survivors from Out-of-Hospital Cardiac Arrest (OHCA) who do not show ST elevation in their EKG will be recruited in the present study. Potentially non-cardiac ethiology of the cardiac arrest will be ruled out prior to randomization. Afterwards, patients will be randomized to emergent or deferred (performed before discharge) coronary angiography. Both groups will receive routine care in the Acute Cardiac Care Unit, including therapeutic hypothermia.
The randomization will be in a 1:1 ratio to urgent or deferred coronary angiography.
The main objective of the study is to compare the effectiveness of an urgent coronary angiography and angioplasty if necessary versus a deferred coronary angiography in survivors from OHCA who after recovery of spontaneous circulation do not fulfill criteria for ST-elevation myocardial infarction.
The primary efficacy endpoint is a composite of in-hospital survival and six-month survival free of severe dependence, which will be evaluated by using the Cerebral Performance Category (CPC) Scale, being good prognosis represented by the categories 1 and 2.The safety endpoint will be a composite of MACE (Major Adverse Cardiac Events) including: death, reinfarction, bleeding or ventricular arrhythmias.
A total of 166 patients will be included. The estimated duration will be 42 months, with a target follow-up of 6 months. Periods will be divided as follows:
- Inclusion Period (selection of the population and data collection): 36 months.
- Monitoring, data analysis, statistical and clinical report: 6 months.
- Conditions
- Cardiac Arrest
- Being tested
- Urgent Coronary Angiography, Deferred Coronary Angiography
- Keywords
- cardiac arrest, survival, neurologic prognosis, coronariography, hypothermia
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent Coronary AngiographyProcedure or surgery
Diagnostic test for the evaluation of the coronary vasculature.
Deferred Coronary AngiographyProcedure or surgery
Diagnostic test for the evaluation of the coronary vasculature.
| Study group | Role | What they receive |
|---|---|---|
| Urgent Coronary Angiography | Experimental | Urgent Coronary Angiography: as soon as possible, when the patient is randomized. Receives: Procedure: Urgent Coronary Angiography |
| Deferred coronariography | Active comparator | Deferred coronary angiography: after extubation if the patient has a good neurologic prognosis. Receives: Procedure: Deferred Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Measured: 30 days.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Measured: 6 months.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Measured: 30 days.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Measured: 6 months.
Secondary outcomes (16)
Hospital survival.
Hospital survival.
Measured: 30 days.
Hospital survival.
Hospital survival.
Measured: 6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Neurological outcome assessed by the Cerebral Performance Category (CPC)
Measured: 30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Neurological outcome assessed by the Cerebral Performance Category (CPC)
Measured: 6 months.
Left ventricular ejection fraction.
Left ventricular ejection fraction.
Measured: 30 days.
Left ventricular ejection fraction.
Left ventricular ejection fraction.
Measured: 6 months.
Infarction size
Defined by the maximum CPK (creatine phosphokinase) and Troponin.
Measured: 30 days.
Vascular complications.
Vascular complications such as pseudoaneurysms, arteriovenous fistulas, etc
Measured: 30 days.
Clinically evident haemorrhagia: BARC> 2
Clinically evident haemorrhagia: BARC> 2
Measured: 30 days.
Sustained ventricular arrythmias or requirement of cardioversion.
Sustained ventricular arrythmias or requirement of cardioversion.
Measured: 30 days.
Renal impairment.
A 50% increase of serum creatinine over a baseline level or an increase of >0.5 mg/dl
Measured: 30 days.
Reinfarction.
According to the Universal Definition of Acute Myocardial Infarction
Measured: 30 days.
Stent Thrombosis
Defined by the Academic Research Consortium (ARC).
Measured: 30 days.
Infections.
Infections.
Measured: 30 days.
Length of intubation.
Length of intubation.
Measured: 30 days.
Length of hospital stay.
Length of hospital stay.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Vall d'Hebron, Hospital Arnau de Vilanova, Hospital Universitari de Bellvitge, Hospital General Universitario Gregorio Marañon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Universitario Ramon y Cajal, Hospital Clinic of Barcelona, Hospital Universitario Virgen Macarena, Hospital Universitario de Canarias, Germans Trias i Pujol Hospital, Complejo Hospitalario Universitario de Santiago, Hospital Universitario Principe de Asturias, Hospital Universitari Joan XXIII de Tarragona., Hospital de Leon
- Responsible party
- Principal investigator, Ana Viana Tejedor, Hospital San Carlos, Madrid
- Investigators
- Ana Viana Tejedor, MD, PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641626
- Sponsor's protocol ID
- COUPE
- Acronym
- COUPE
- Status last verified
- Aug 2021
- First submitted
- 20 Dec 2015
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camuglia AC, Randhawa VK, Lavi S, Walters DL. Cardiac catheterization is associated with superior outcomes for survivors of out of hospital cardiac arrest: review and meta-analysis. Resuscitation. 2014 Nov;85(11):1533-40. doi: 10.1016/j.resuscitation.2014.08.025. Epub 2014 Sep 4.
PubMed 25195073Morrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Hoek TV, Halverson CC, Doering L, Peberdy MA, Edelson DP; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on P. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus statement from the American Heart Association. Circulation. 2013 Apr 9;127(14):1538-63. doi: 10.1161/CIR.0b013e31828b2770. Epub 2013 Mar 11. No abstract available.
PubMed 23479672Viana-Tejedor A, Andrea-Riba R, Scardino C, Ariza-Sole A, Baneras J, Garcia-Garcia C, Jimenez Mena M, Vila M, Martinez-Selles M, Pastor G, Garcia Acuna JM, Loma-Osorio P, Garcia Rubira JC, Jorge Perez P, Pastor P, Ferrera C, Noriega FJ, Perez Macias N, Fernandez-Ortiz A, Perez-Villacastin J; COUPE Investigators. Coronary angiography in patients without ST-segment elevation following out-of-hospital cardiac arrest. COUPE clinical trial. Rev Esp Cardiol (Engl Ed). 2023 Feb;76(2):94-102. doi: 10.1016/j.rec.2022.05.013. Epub 2022 Jun 22. English, Spanish.
PubMed 35750580
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT02641626
- Acronym / sponsor ID
- COUPE / COUPE
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, survival, neurologic prognosis, coronariography, hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Vall d'Hebron, Hospital Arnau de Vilanova, Hospital Universitari de Bellvitge, Hospital General Universitario Gregorio Marañon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Universitario Ramon y Cajal, Hospital Clinic of Barcelona, Hospital Universitario Virgen Macarena, Hospital Universitario de Canarias, Germans Trias i Pujol Hospital, Complejo Hospitalario Universitario de Santiago, Hospital Universitario Principe de Asturias, Hospital Universitari Joan XXIII de Tarragona., Hospital de Leon
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 29 Dec 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.
Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited. Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.
Detailed description
Prospective, multicenter and randomized clinical trial. Survivors from Out-of-Hospital Cardiac Arrest (OHCA) who do not show ST elevation in their EKG will be recruited in the present study. Potentially non-cardiac ethiology of the cardiac arrest will be ruled out prior to randomization. Afterwards, patients will be randomized to emergent or deferred (performed before discharge) coronary angiography. Both groups will receive routine care in the Acute Cardiac Care Unit, including therapeutic hypothermia.
The randomization will be in a 1:1 ratio to urgent or deferred coronary angiography.
The main objective of the study is to compare the effectiveness of an urgent coronary angiography and angioplasty if necessary versus a deferred coronary angiography in survivors from OHCA who after recovery of spontaneous circulation do not fulfill criteria for ST-elevation myocardial infarction.
The primary efficacy endpoint is a composite of in-hospital survival and six-month survival free of severe dependence, which will be evaluated by using the Cerebral Performance Category (CPC) Scale, being good prognosis represented by the categories 1 and 2.The safety endpoint will be a composite of MACE (Major Adverse Cardiac Events) including: death, reinfarction, bleeding or ventricular arrhythmias.
A total of 166 patients will be included. The estimated duration will be 42 months, with a target follow-up of 6 months. Periods will be divided as follows:
- Inclusion Period (selection of the population and data collection): 36 months.
- Monitoring, data analysis, statistical and clinical report: 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent Coronary Angiography | Experimental | Procedure: Urgent Coronary AngiographyUrgent Coronary Angiography: as soon as possible, when the patient is randomized. |
| Deferred coronariography | Active comparator | Procedure: Deferred Coronary AngiographyDeferred coronary angiography: after extubation if the patient has a good neurologic prognosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Age <18 years.
- Pregnant women or women of childbearing age unless they have a negative pregnancy test.
- Time to return of spontaneous circulation longer than 60 minutes.
- Non-cardiac etiology of the comatose state: drug overdose, head injury or stroke.
- Acute myocardial infarction with ST segment elevation or left bundle branch block, because in those patients emergent angiography is mandatory.
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 |
|---|---|---|
| Urgent Coronary AngiographyDiagnostic test for the evaluation of the coronary vasculature. | Procedure or surgery | Urgent Coronary Angiography |
| Deferred Coronary AngiographyDiagnostic test for the evaluation of the coronary vasculature. | Procedure or surgery | Deferred coronariography |
Primary outcome
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Time frame: 30 days.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Time frame: 6 months.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Time frame: 30 days.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Time frame: 6 months.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
16 secondary outcomes
Hospital survival.
Time frame: 30 days.
Hospital survival.
Time frame: 6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Time frame: 30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Time frame: 6 months.
Left ventricular ejection fraction.
Time frame: 30 days.
Left ventricular ejection fraction.
Time frame: 6 months.
Infarction size
Time frame: 30 days.
Vascular complications.
Time frame: 30 days.
Clinically evident haemorrhagia: BARC> 2
Time frame: 30 days.
Sustained ventricular arrythmias or requirement of cardioversion.
Time frame: 30 days.
Renal impairment.
Time frame: 30 days.
Reinfarction.
Time frame: 30 days.
Stent Thrombosis
Time frame: 30 days.
Infections.
Time frame: 30 days.
Length of intubation.
Time frame: 30 days.
Length of hospital stay.
Time frame: 6 months.
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 30 Aug 2021.
- Results publication: PubMed 25195073Camuglia AC, Randhawa VK, Lavi S, Walters DL. Cardiac catheterization is associated with superior outcomes for survivors of out of hospital cardiac arrest: review and meta-analysis. Resuscitation. 2014 Nov;85(11):1533-40. doi: 10.1016/j.resuscitation.2014.08.025. Epub 2014 Sep 4.
- Results publication: PubMed 23479672Morrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Hoek TV, Halverson CC, Doering L, Peberdy MA, Edelson DP; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on P. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus statement from the American Heart Association. Circulation. 2013 Apr 9;127(14):1538-63. doi: 10.1161/CIR.0b013e31828b2770. Epub 2013 Mar 11. No abstract available.
- Derived from this study: PubMed 35750580Viana-Tejedor A, Andrea-Riba R, Scardino C, Ariza-Sole A, Baneras J, Garcia-Garcia C, Jimenez Mena M, Vila M, Martinez-Selles M, Pastor G, Garcia Acuna JM, Loma-Osorio P, Garcia Rubira JC, Jorge Perez P, Pastor P, Ferrera C, Noriega FJ, Perez Macias N, Fernandez-Ortiz A, Perez-Villacastin J; COUPE Investigators. Coronary angiography in patients without ST-segment elevation following out-of-hospital cardiac arrest. COUPE clinical trial. Rev Esp Cardiol (Engl Ed). 2023 Feb;76(2):94-102. doi: 10.1016/j.rec.2022.05.013. Epub 2022 Jun 22. English, Spanish.
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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.
Ana Viana Tejedor, MD, PhD principal investigator
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgent Coronary Angiography and Deferred Coronary Angiography in people with Cardiac Arrest, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 0 inclusion and 8 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 30 Aug 2021. 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 Spain. 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?
Survival with good neurological outcome for activities of daily living (CPC 1-2). (time frame: 30 days.). The study lists 4 primary outcomes in all. 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 NCT02641626, which also lists 3 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 30 Aug 2021.