Out of Hospital Cardiac Arrest Without ST-segment ElevationPERFECCTNCT05961488
Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
A study testing Coronary Calcium Score and Coronary CT angiogram in people with Out of Hospital Cardiac Arrest Without ST-segment Elevation, run by CHU de Reims at 1 site in France.
Trial summary
Out-of-hospital cardiac arrest (OHCA) has multiple etiologies. In the absence of ST-elevation myocardial infarction, percutaneous coronary intervention (PCI) is delayed. This study aims to determine the diagnostic accuracy of Coronary Calcium Score (CCS) and Coronary CT Angiogram (CCTA) to rule out a coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest Without ST-segment Elevation
- What is being tested?
- Coronary Calcium Score and Coronary CT angiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2024to Jan 2028
- 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 hospitalized in intensive care unit after a resuscitated out-of-hospital cardiac arrest
- No obvious cause for sudden death on anamnestic information, CT brain and CT pulmonary angiogram.
- Absence of ST elevation myocardial infarction
- Non-inclusion criteria :
- In-hospital cardiac arrest
- Refractory cardiac arrest
Show all 15Show fewer
- Indication of immediate coronary angiography
- ST-elevation myocardial infarction or unknown left bundle branch block
- Dynamic or presumably new contiguous ST/T-segment changes
- Cardiogenic shock
- Life-threatening arrhythmias
- Coronary artery bypass graft
- Pregnancy
- Multiple organ failure syndrome
- Know severe chronic kidney disease (GFR <30mL/min/1,73m²)
Who cannot join
- During the Coronary computerized tomographic angiogram :
- Haemodynamic instability requiring high dose of vasopressors (>1µg/kg/min of Norepinephrine)
- Non sinusal cardiac rhythm
- KDIGO 1 Acute kidney injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Antoine GOURY, 03 10 73 68 85 ext. 0033, agoury@chu-reims.fr
Bruno MOURVILLIER, 03 10 73 66 20 ext. 0033, bmourvillier@chu-reims.fr
About this study
Out-of-hospital cardiac arrest (OHCA) has multiple etiologies. In the absence of ST-elevation myocardial infarction, percutaneous coronary intervention (PCI) is delayed. This study aims to determine the diagnostic accuracy of Coronary Calcium Score (CCS) and Coronary CT Angiogram (CCTA) to rule out a coronary artery disease (CAD) in the first days after an OHCA.
Read the detailed description
Each year, 50.000 out-of-hospital cardiac arrest (OHCA) occur in France. Acute myocardial infarction (AMI) is one of the most frequent etiology of OHCA. When a cardiac arrest is due to a ST-elevation myocardial infarction (STEMI), a percutaneous coronary intervention (PCI) is realized in emergency. However, without ST-elevation, PCI timing is unclear. 2020 European Society Recommandations suggest that PCI should not be realized in emergency, based on Lemkes and al. clinical trial. But there is scarce evidence about the exact timing to realize PCI. Electrocardiogram, troponin level, and echocardiography are unprecise to rule-out an ischemic etiology of cardiac arrest.
A brain CT-scan and a CT-pulmonary angiogram are recommended in first place, to identify the etiology of the cardiac arrest if there is no ST-elevation nor obvious causes. Nevertheless, in the absence of scanographic abnormality, a differed coronary angiogram should be realized.
We suggest that coronary CT angiogram (CCTA) and coronary calcium score (CCS) are feasible in the first days of hospitalization, and could rule-out a coronary artery disease (CAD). The aim of the study is to avoid an invasive coronary exploration, and to have a quick answer about anti-thrombotic treatments management.
- Being tested
- Coronary Calcium Score and Coronary CT angiogram
- Keywords
- Cardiac arrest, Diagnostic accuracy, Coronary computarized tomography angiogram, Coronary Calcium Score, Non-ST Elevated Myocardial Infarction
- Medical subject headings
- Heart Arrest, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Calcium Score and Coronary CT angiogramOther
Introduction of early Coronary CT angiogram and Coronary Calcium Score in the first days after a resuscitated out-of-hospital cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: Coronary Calcium Score and Coronary CT angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%
Measured: During hospitalization (maximum 7 days from ICU admission)
Secondary outcomes (6)
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
Measured: During hospitalization (maximum 7 days from ICU admission)
Cororany calcium score associated with coronary stenosis between 50% and 70%
Measured: During hospitalization (maximum 7 days from ICU admission)
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram associated with Coronary Calcium Score compared to CCTA performance alone
Measured: During hospitalization (maximum 7 days from ICU admission)
Incidence of contrast associated acute kidney injury
Measured: Day 15
Comparison of contrast volume between CCTA and percutaneous coronary intervention
Measured: During hospitalization (maximum 7 days from ICU admission)
Comparison of radiation dose between CCTA and percutaneous coronary intervention
Measured: During hospitalization (maximum 7 days from ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start4 Mar 2024
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac Arrest Without ST-segment ElevationStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961488
- Sponsor's protocol ID
- PA23075
- Acronym
- PERFECCT
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05961488
- Acronym / sponsor ID
- PERFECCT / PA23075
- Keywords
- Cardiac arrest, Diagnostic accuracy, Coronary computarized tomography angiogram, Coronary Calcium Score, Non-ST Elevated Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- 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.
Out-of-hospital cardiac arrest (OHCA) has multiple etiologies. In the absence of ST-elevation myocardial infarction, percutaneous coronary intervention (PCI) is delayed. This study aims to determine the diagnostic accuracy of Coronary Calcium Score (CCS) and Coronary CT Angiogram (CCTA) to rule out a coronary artery disease (CAD) in the first days after an OHCA.
Detailed description
Each year, 50.000 out-of-hospital cardiac arrest (OHCA) occur in France. Acute myocardial infarction (AMI) is one of the most frequent etiology of OHCA. When a cardiac arrest is due to a ST-elevation myocardial infarction (STEMI), a percutaneous coronary intervention (PCI) is realized in emergency. However, without ST-elevation, PCI timing is unclear. 2020 European Society Recommandations suggest that PCI should not be realized in emergency, based on Lemkes and al. clinical trial. But there is scarce evidence about the exact timing to realize PCI. Electrocardiogram, troponin level, and echocardiography are unprecise to rule-out an ischemic etiology of cardiac arrest.
A brain CT-scan and a CT-pulmonary angiogram are recommended in first place, to identify the etiology of the cardiac arrest if there is no ST-elevation nor obvious causes. Nevertheless, in the absence of scanographic abnormality, a differed coronary angiogram should be realized.
We suggest that coronary CT angiogram (CCTA) and coronary calcium score (CCS) are feasible in the first days of hospitalization, and could rule-out a coronary artery disease (CAD). The aim of the study is to avoid an invasive coronary exploration, and to have a quick answer about anti-thrombotic treatments management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Coronary Calcium Score and Coronary CT angiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients hospitalized in intensive care unit after a resuscitated out-of-hospital cardiac arrest
- No obvious cause for sudden death on anamnestic information, CT brain and CT pulmonary angiogram.
- Absence of ST elevation myocardial infarction
- In-hospital cardiac arrest
- Refractory cardiac arrest
Key exclusion criteria (4 listed)
- During the Coronary computerized tomographic angiogram :
- Haemodynamic instability requiring high dose of vasopressors (>1µg/kg/min of Norepinephrine)
- Non sinusal cardiac rhythm
- KDIGO 1 Acute kidney injury
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 |
|---|---|---|
| Coronary Calcium Score and Coronary CT angiogramIntroduction of early Coronary CT angiogram and Coronary Calcium Score in the first days after a resuscitated out-of-hospital cardiac arrest. | Other | Patients |
Primary outcome
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%
Time frame: During hospitalization (maximum 7 days from ICU admission)
6 secondary outcomes
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
Time frame: During hospitalization (maximum 7 days from ICU admission)
Cororany calcium score associated with coronary stenosis between 50% and 70%
Time frame: During hospitalization (maximum 7 days from ICU admission)
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram associated with Coronary Calcium Score compared to CCTA performance alone
Time frame: During hospitalization (maximum 7 days from ICU admission)
Incidence of contrast associated acute kidney injury
Time frame: Day 15
Comparison of contrast volume between CCTA and percutaneous coronary intervention
Time frame: During hospitalization (maximum 7 days from ICU admission)
Comparison of radiation dose between CCTA and percutaneous coronary intervention
Time frame: During hospitalization (maximum 7 days from ICU admission)
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 6 Mar 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Calcium Score and Coronary CT angiogram in people with Out of Hospital Cardiac Arrest Without ST-segment Elevation, run by CHU de Reims at 1 site in France.
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 15 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. 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 France. 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?
Contact Antoine GOURY (03 10 73 68 85 ext. 0033, agoury@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50% (time frame: During hospitalization (maximum 7 days from ICU admission)). 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 6 Mar 2024.