Unstable AnginaICARNCT06378333
Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area.
An observational study of Unstable Angina, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Unstable Angina
- What is being tested?
- patients who underwent coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2022to 15 Apr 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unstable angina proven by coronary angiography admitted to Montpellier and Nîmes hospitals between November 2021 and January 2023.
Who may be able to join
- Patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis.
- Ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram.
- hs-cTn concentrations are in the normal range or may be slightly elevated > 99th percentile (i.e. low troponin T elevation ≤ 50 * Elecsys Roche) but with absence of significant kinetics according to criteria defined in the literature (<20%).
- One of the following angiographic criteria is required:
- Coronary angiography revealing a stenosis with a diameter of at least 70%.
- Stenosis of at least 50% diameter in the left common trunk.
- FFR (Fractional Flow Reserve) documenting ischemia per coronary angiography of a coronary lesion in the case of intermediate stenosis (50-70%).
- If there are no significant lesions, a spasm must be proven by an ergonovine test.
Who cannot join
- NSTEMI and STEMI.
- Coronaries normal or without significant lesions unless proven spasm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. ICAR Observational Study
The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations < 99 percentile (undetectable: <5ng/l or non-elevated: <14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes).
- Conditions
- Unstable Angina
- Being tested
- patients who underwent coronary angiography
- Keywords
- cardiology
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients who underwent coronary angiographyProcedure or surgery
All patients included in the ICAR project (Montpellier - Nîmes) benefit from a consultation at one year (12+or - 2 months), as they are systematically reviewed in our department: data will therefore be collected in the patient's medical record. Clinical biological parameters and events during the hospital phase are also collected in the patient's computerized record. Normal patient management remains unchanged.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hospitalisation for unstable angina
Measured: One year after hospitalisation for of unstable Angina
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start27 Nov 2022
- Primary completion27 Jan 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Unstable AnginaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378333
- Sponsor's protocol ID
- 2024-01-023
- Acronym
- ICAR
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. doi: 10.1161/01.cir.102.1.118.
PubMed 10880424Puelacher C, Gugala M, Adamson PD, Shah A, Chapman AR, Anand A, Sabti Z, Boeddinghaus J, Nestelberger T, Twerenbold R, Wildi K, Badertscher P, Rubini Gimenez M, Shrestha S, Sazgary L, Mueller D, Schumacher L, Kozhuharov N, Flores D, du Fay de Lavallaz J, Miro O, Martin-Sanchez FJ, Morawiec B, Fahrni G, Osswald S, Reichlin T, Mills NL, Mueller C. Incidence and outcomes of unstable angina compared with non-ST-elevation myocardial infarction. Heart. 2019 Sep;105(18):1423-1431. doi: 10.1136/heartjnl-2018-314305. Epub 2019 Apr 24.
PubMed 31018955Kristensen AMD, Pareek M, Kragholm KH, Sehested TSG, Olsen MH, Prescott EB. Unstable Angina as a Component of Primary Composite Endpoints in Clinical Cardiovascular Trials: Pros and Cons. Cardiology. 2022;147(3):235-247. doi: 10.1159/000524948. Epub 2022 May 10.
PubMed 35537418Eggers KM, Jernberg T, Lindahl B. Unstable Angina in the Era of Cardiac Troponin Assays with Improved Sensitivity-A Clinical Dilemma. Am J Med. 2017 Dec;130(12):1423-1430.e5. doi: 10.1016/j.amjmed.2017.05.037. Epub 2017 Jun 21.
PubMed 28647406Vafaie M, Slagman A, Mockel M, Hamm C, Huber K, Muller C, Vollert JO, Blankenberg S, Katus HA, Liebetrau C, Giannitsis E, Searle J. Prognostic Value of Undetectable hs Troponin T in Suspected Acute Coronary Syndrome. Am J Med. 2016 Mar;129(3):274-82.e2. doi: 10.1016/j.amjmed.2015.10.016. Epub 2015 Oct 30.
PubMed 26524709Olivier CB, Sundaram V, Bhatt DL, Leonardi S, Lopes RD, Ding VY, Yang L, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, White HD, Desai M, Lynch DR Jr, Harrington RA, Mahaffey KW; CHAMPION PLATFORM and CHAMPION PCI Investigators. Definitions of peri-procedural myocardial infarction and the association with one-year mortality: Insights from CHAMPION trials. Int J Cardiol. 2018 Nov 1;270:96-101. doi: 10.1016/j.ijcard.2018.06.034. Epub 2018 Jun 8.
PubMed 29937301Jouen R, Meunier PA, Moulis L, Roubille F, Macia JC, Berdeu JM, Steinecker M, Robert P, Lattuca B, Cayla G, Leclercq F. Incidence and 1-Year Prognostic of Unstable Angina After High-Sensitivity Troponin Assessment. Catheter Cardiovasc Interv. 2025 May;105(6):1445-1452. doi: 10.1002/ccd.31473. Epub 2025 Mar 6.
PubMed 40047210
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. ICAR Observational Study
- ClinicalTrials.gov ID
- NCT06378333
- Acronym / sponsor ID
- ICAR / 2024-01-023
- Conditions
- Unstable Angina
- Keywords
- cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 22 Apr 2024 (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.
The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations < 99 percentile (undetectable: <5ng/l or non-elevated: <14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unstable angina proven by coronary angiography admitted to Montpellier and Nîmes hospitals between November 2021 and January 2023.
Key inclusion criteria (8 listed)
- Patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis.
- Ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram.
- hs-cTn concentrations are in the normal range or may be slightly elevated > 99th percentile (i.e. low troponin T elevation ≤ 50 * Elecsys Roche) but with absence of significant kinetics according to criteria defined in the literature (<20%).
- One of the following angiographic criteria is required:
Key exclusion criteria (2 listed)
- NSTEMI and STEMI.
- Coronaries normal or without significant lesions unless proven spasm.
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 |
|---|---|---|
| patients who underwent coronary angiographyAll patients included in the ICAR project (Montpellier - Nîmes) benefit from a consultation at one year (12+or - 2 months), as they are systematically reviewed in our department: data will therefore be collected in the patient's medical record. Clinical biological parameters and events during the hospital phase are also collected in the patient's computerized record. Normal patient management remains unchanged. | Procedure or surgery | – |
Primary outcome
Number of patients with hospitalisation for unstable angina
Time frame: One year after hospitalisation for of unstable Angina
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 2 May 2024.
- Background: PubMed 10880424Hamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. doi: 10.1161/01.cir.102.1.118.
- Background: PubMed 31018955Puelacher C, Gugala M, Adamson PD, Shah A, Chapman AR, Anand A, Sabti Z, Boeddinghaus J, Nestelberger T, Twerenbold R, Wildi K, Badertscher P, Rubini Gimenez M, Shrestha S, Sazgary L, Mueller D, Schumacher L, Kozhuharov N, Flores D, du Fay de Lavallaz J, Miro O, Martin-Sanchez FJ, Morawiec B, Fahrni G, Osswald S, Reichlin T, Mills NL, Mueller C. Incidence and outcomes of unstable angina compared with non-ST-elevation myocardial infarction. Heart. 2019 Sep;105(18):1423-1431. doi: 10.1136/heartjnl-2018-314305. Epub 2019 Apr 24.
- Background: PubMed 35537418Kristensen AMD, Pareek M, Kragholm KH, Sehested TSG, Olsen MH, Prescott EB. Unstable Angina as a Component of Primary Composite Endpoints in Clinical Cardiovascular Trials: Pros and Cons. Cardiology. 2022;147(3):235-247. doi: 10.1159/000524948. Epub 2022 May 10.
- Background: PubMed 28647406Eggers KM, Jernberg T, Lindahl B. Unstable Angina in the Era of Cardiac Troponin Assays with Improved Sensitivity-A Clinical Dilemma. Am J Med. 2017 Dec;130(12):1423-1430.e5. doi: 10.1016/j.amjmed.2017.05.037. Epub 2017 Jun 21.
- Background: PubMed 26524709Vafaie M, Slagman A, Mockel M, Hamm C, Huber K, Muller C, Vollert JO, Blankenberg S, Katus HA, Liebetrau C, Giannitsis E, Searle J. Prognostic Value of Undetectable hs Troponin T in Suspected Acute Coronary Syndrome. Am J Med. 2016 Mar;129(3):274-82.e2. doi: 10.1016/j.amjmed.2015.10.016. Epub 2015 Oct 30.
- Background: PubMed 29937301Olivier CB, Sundaram V, Bhatt DL, Leonardi S, Lopes RD, Ding VY, Yang L, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, White HD, Desai M, Lynch DR Jr, Harrington RA, Mahaffey KW; CHAMPION PLATFORM and CHAMPION PCI Investigators. Definitions of peri-procedural myocardial infarction and the association with one-year mortality: Insights from CHAMPION trials. Int J Cardiol. 2018 Nov 1;270:96-101. doi: 10.1016/j.ijcard.2018.06.034. Epub 2018 Jun 8.
- Derived from this study: PubMed 40047210Jouen R, Meunier PA, Moulis L, Roubille F, Macia JC, Berdeu JM, Steinecker M, Robert P, Lattuca B, Cayla G, Leclercq F. Incidence and 1-Year Prognostic of Unstable Angina After High-Sensitivity Troponin Assessment. Catheter Cardiovasc Interv. 2025 May;105(6):1445-1452. doi: 10.1002/ccd.31473. Epub 2025 Mar 6.
- 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.
Florence Leclercq, PUPH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Angina, run by University Hospital, Montpellier 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 8 inclusion and 2 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 2 May 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?
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?
Number of patients with hospitalisation for unstable angina (time frame: One year after hospitalisation for of unstable Angina). 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 NCT06378333, which also lists 7 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 2 May 2024.