Acute Coronary SyndromeNCT03218007
A2 AR as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
A study testing blood samples in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
One proposed strategy is the stratification of troponin-negative patients with biomarker testing at presentation to facilitate the clinically-appropriate rapid discharge from the emergency department of patients who present with low-intermediate risk chest pain, and conversely to triage appropriate Non sustained ST… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2017to 15 May 2019
- 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
- A subject with a symptomatology consistent with acute coronary syndrome for at least 15 min and less than 6 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or both arms, pain in the jaw, Pain in the back / neck / stomach, dyspnea, cold sweats, nausea / vomiting, dizziness)
- Man or woman,
- over 18 years,
- Patient agreeing to participate in the study and having signed informed consent.
Who cannot join
- Minor Patient
- Patient not having signed informed consent (refusal, physical or mental incapacity ...) --Patient with an evolutive septic process, neoplasia undergoing treatment, dialysed renal insufficiency, history of surgery or coronary angioplasty less than six months old.
- Cardiac, renal or hepatic transplantation
- elevation of troponin
- Cardiac arrest
- A subject whose symptomatology clearly eliminates acute coronary syndrome (penetrating trauma, traumatic lesion by crushing ...)
Show all 13Show fewer
- Patient who died between the time of inclusion and arrival in cardiology intensive care (ICU)
- Patient withdrawing consent during study
- Vulnerable people unable to fully integrate the objectives, benefits and risks of research and to give their informed consent
- Pregnant women
- Persons deprived of their liberty
- Persons admitted to health and social facilities for therapeutic purposes
- Protected persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2A Receptor (A2 AR) as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
One proposed strategy is the stratification of troponin-negative patients with biomarker testing at presentation to facilitate the clinically-appropriate rapid discharge from the emergency department of patients who present with low-intermediate risk chest pain, and conversely to triage appropriate Non sustained ST elevation acute coronary syndrome (NSTE-ACS) patients to Cardiology beds, stress and non-invasive imaging modalities. Biomarkers such as high-sensitivity troponin (hs-cTn), heart-type fatty acid-binding protein (H-FABP), CRP, brain natriuretic peptide (BNP); and copeptin and ischemia-modified albumin are an important advance for diagnostic testing for ACS (4). Regarding novel biomarker testing at presentation, the addition of these biomarkers demonstrated increased sensitivity at an acceptable QALY threshold, but more evidence is needed (5,6). A reliable method for the diagnosis of minimal cardiac ischemia would meet a strong demand for the sensitive diagnosis of coronary artery disease in patients with chest pain but unremarkable ECGs and biomarkers. Adenosine is an endogenous nucleoside cardioprotective agent. Its cardiovascular effects are mediated throught the activation of A2A Receptor (A2 AR) and play a major role in the regulation of Coronary flow CF. As altered coronary blood flow occurs in patients with CAD, it has been showed that that A2AR expression and functional activity play a role in CAD. In a previous studies the team have developped an agonist-like monoclonal antibody to study expression level of this receptor and their functional activity. Recently , Gariboldi demonstrated that measuring the expression level of A2AR on peripheral blood mononuclear cells ( PBMC) represents a good tool to address in situ expression in coronary tissues of CAD patients.
Read the detailed description
In the diagnostic setting of ACS, expression and functionnaly activity of A2AR could be a sensitive detection method for ischemia. It would be a powerful tool for risk stratification of patients presenting with chest pain but unremarkable ECG and blood tests. the investigateors therefore designed a blind multicentrique prospective study to evaluate expression and functionnaly activity of A2AR in the management of undifferentiated chest pain The objective of the study was to evaluate diagnostic accuracy between this novel biomarkers A2AR and invasive and non -invasive evaluation of patients with suspected coronary artery disease (CAD).
- Conditions
- Acute Coronary Syndrome
- Being tested
- blood samples
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
to evaluate expression and functionnaly activity of A2AR
| Study group | Role | What they receive |
|---|---|---|
| acute coronary syndrome | Experimental | Not described Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of adenosine
evaluate expression and functionnaly activity of A2AR
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Nov 2017
- Primary completion15 May 2019
- Study completion15 May 2019
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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218007
- Sponsor's protocol ID
- 2017-36
- Other IDs
- 2017-A01836-47
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paganelli F, Resseguier N, Marlinge M, Laine M, Malergue F, Kipson N, Armangau P, Pezzoli N, Kerbaul F, Bonello L, Mottola G, Fenouillet E, Guieu R, Ruf J. Specific Pharmacological Profile of A2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease. J Am Heart Assoc. 2018 Apr 13;7(8):e008290. doi: 10.1161/JAHA.117.008290.
PubMed 29654194
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2A Receptor (A2 AR) as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
- ClinicalTrials.gov ID
- NCT03218007
- Acronym / sponsor ID
- 2017-36
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 14 Jul 2017 (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.
One proposed strategy is the stratification of troponin-negative patients with biomarker testing at presentation to facilitate the clinically-appropriate rapid discharge from the emergency department of patients who present with low-intermediate risk chest pain, and conversely to triage appropriate Non sustained ST elevation acute coronary syndrome (NSTE-ACS) patients to Cardiology beds, stress and non-invasive imaging modalities. Biomarkers such as high-sensitivity troponin (hs-cTn), heart-type fatty acid-binding protein (H-FABP), CRP, brain natriuretic peptide (BNP); and copeptin and ischemia-modified albumin are an important advance for diagnostic testing for ACS (4). Regarding novel biomarker testing at presentation, the addition of these biomarkers demonstrated increased sensitivity at an acceptable QALY threshold, but more evidence is needed (5,6). A reliable method for the diagnosis of minimal cardiac ischemia would meet a strong demand for the sensitive diagnosis of coronary artery disease in patients with chest pain but unremarkable ECGs and biomarkers. Adenosine is an endogenous nucleoside cardioprotective agent. Its cardiovascular effects are mediated throught the activation of A2A Receptor (A2 AR) and play a major role in the regulation of Coronary flow CF. As altered coronary blood flow occurs in patients with CAD, it has been showed that that A2AR expression and functional activity play a role in CAD. In a previous studies the team have developped an agonist-like monoclonal antibody to study expression level of this receptor and their functional activity. Recently , Gariboldi demonstrated that measuring the expression level of A2AR on peripheral blood mononuclear cells ( PBMC) represents a good tool to address in situ expression in coronary tissues of CAD patients.
Detailed description
In the diagnostic setting of ACS, expression and functionnaly activity of A2AR could be a sensitive detection method for ischemia. It would be a powerful tool for risk stratification of patients presenting with chest pain but unremarkable ECG and blood tests. the investigateors therefore designed a blind multicentrique prospective study to evaluate expression and functionnaly activity of A2AR in the management of undifferentiated chest pain The objective of the study was to evaluate diagnostic accuracy between this novel biomarkers A2AR and invasive and non -invasive evaluation of patients with suspected coronary artery disease (CAD).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndrome | Experimental | Biological: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A subject with a symptomatology consistent with acute coronary syndrome for at least 15 min and less than 6 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or both arms, pain in the jaw, Pain in the back / neck / stomach, dyspnea, cold sweats, nausea / vomiting, dizziness)
- Man or woman,
- over 18 years,
- Patient agreeing to participate in the study and having signed informed consent.
Key exclusion criteria (13 listed)
- Minor Patient
- Patient not having signed informed consent (refusal, physical or mental incapacity ...) --Patient with an evolutive septic process, neoplasia undergoing treatment, dialysed renal insufficiency, history of surgery or coronary angioplasty less than six months old.
- Cardiac, renal or hepatic transplantation
- elevation of troponin
- Cardiac arrest
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 |
|---|---|---|
| blood samplesto evaluate expression and functionnaly activity of A2AR | Biological | acute coronary syndrome |
Primary outcome
dosage of adenosine
Time frame: 12 MONTHS
evaluate expression and functionnaly activity of A2AR
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 12 Oct 2021.
- Derived from this study: PubMed 29654194Paganelli F, Resseguier N, Marlinge M, Laine M, Malergue F, Kipson N, Armangau P, Pezzoli N, Kerbaul F, Bonello L, Mottola G, Fenouillet E, Guieu R, Ruf J. Specific Pharmacological Profile of A2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease. J Am Heart Assoc. 2018 Apr 13;7(8):e008290. doi: 10.1161/JAHA.117.008290.
- Individual participant dataSharing planned: No
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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.
Jean-Olivier ARNAUD study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 13 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 12 Oct 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 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?
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?
dosage of adenosine (time frame: 12 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 NCT03218007, 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 12 Oct 2021.