NSTEMINCT07204847
Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI
An observational study of NSTEMI and NSTE-ACS (NSTEMI and UA), run by University Hospital, Montpellier at 1 site in France.
Trial summary
The objective of this multicentric observational study is to evaluate the prognostic influence of adherence or non-adherence to the recommended coronary angiography timeframe (within 24 hours) and the six-month prognosis of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSTEMI, NSTE-ACS (NSTEMI and UA), NSTEMI - Non-ST-Segment Elevation Myocardial Infarction
- How many people
- 407 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 20 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The included patients are those diagnosed with NSTEMI who have undergone coronary angiography as recommended, with no changes to the subsequent patient follow-up
Who may be able to join
- Presence of chest pain with or without ECG changes
- Elevation of troponin level > 90th percentile or a significant increase between two dosages
- Significant or non-significant coronary lesion confirming the diagnosis of coronary artery disease on coronary angiography (coronary angiography mandatory before inclusion to confirm NSTEMI)
Who cannot join
- STEMI (ST-segment elevation myocardial infarction) or equivalent (defined as chest pain with ECG changes and troponin elevation > 5 times the normal with an occluded artery (TIMI 0, 1, or 2) during initial coronary angiography)
- Very high-risk NSTEMI (hemodynamic instability, cardiogenic shock, recurrent/refractory chest pain despite optimal medical treatment, life-threatening arrhythmia, mechanical complication, heart failure clearly related to NSTEMI, ST depression > 1mm/6 leads with ST elevation in aVR and/or V1) for which urgent coronary angiography is mandatory
- Unstable angina (acute coronary syndrome without troponin elevation)
- Troponin elevation without chest pain or symptoms suggestive of NSTEMI
- Recovered cardiac arrest
- Contraindication to coronary revascularization or coronary angiography
- Other diagnoses considered after coronary angiography (e.g., myocarditis, Takotsubo syndrome)
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI: a Prospective Real-world Study
The objective of this multicentric observational study is to evaluate the prognostic influence of adherence or non-adherence to the recommended coronary angiography timeframe (within 24 hours) and the six-month prognosis of the patients.
Read the detailed description
Primary Objective: To describe the predictive values (sensitivity and specificity) of the timing of coronary angiography after the diagnosis of NSTEMI.
Secondary Objective: To evaluate an optimal threshold for the timing of coronary angiography that predicts poor prognosis at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) (MACCE = Major Adverse Cardiac and Cerebral Events, stroke = cerebrovascular accident).
Comparisons:
Comparison of severe events at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 6 months (all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, considered separately) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 1 month (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of the occurrence of severe events (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, treated as survival data) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Additional Descriptions:
Description of the prevalence of patients for whom the recommended timing of coronary angiography is followed.
Comparison of the characteristics of patients who underwent coronary angiography within 24 hours versus those who did not (age, LVEF (left ventricular ejection fraction), troponin level, creatinine, NYHA class (New York Heart Association heart failure classification)).
Comparison of the length of hospitalization based on the timing of coronary angiography.
- Keywords
- NSTEMI, NSTE-ACS, Invasive strategy timing, Early or delayed intervention
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Invasive coronary angiography within 24 hours after diagnosis | |
| Delayed intervention | Invasive coronary angiography more than 24 hours after diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months
Sensibility and specificity, positive and negative predictive values
Measured: From enrollment to 6 months
Secondary outcomes (7)
Evaluation of the optimal timing of invasive coronary angiography predicting a negative outcome at 6 months
Using a receiver operating characteristic (ROC) curve
Measured: From enrollment to 6 months
Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 6 months
Composite of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure
Measured: From enrollment to 6 months
Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 1 month
Composite criteria of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure
Measured: From enrollment to 1 month
Comparison of each element of the composite criteria individually at 6 months of an invasive coronary angiography within 24h and after 24h
Overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure
Measured: From enrollment to 6 months
Describe the prevalence of patients receiving an invasive in respect to the timing of the guidelines
Within 24 hours
Measured: At enrollment
Comparison of major bleeding at 6 months
Measured: From enrollment to 6 months
Length of in-patient stay
Duration in days between the date of admission at the participating hospital and the date of discharge during the index hospitalization
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 posted2 Oct 2025
- Study start1 Nov 2023
- Primary completion1 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NSTEMIStudies 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
- Prospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Nīmes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204847
- Sponsor's protocol ID
- 2024-12-185
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.
PubMed 20359842Mehta 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 19458363Kofoed 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 30565996Kite TA, Kurmani SA, Bountziouka V, Cooper NJ, Lock ST, Gale CP, Flather M, Curzen N, Banning AP, McCann GP, Ladwiniec A. Timing of invasive strategy in non-ST-elevation acute coronary syndrome: a meta-analysis of randomized controlled trials. Eur Heart J. 2022 Sep 1;43(33):3148-3161. doi: 10.1093/eurheartj/ehac213.
PubMed 35514079
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI: a Prospective Real-world Study
- ClinicalTrials.gov ID
- NCT07204847
- Acronym / sponsor ID
- 2024-12-185
- Keywords
- NSTEMI, NSTE-ACS, Invasive strategy timing, Early or delayed intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Nīmes
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 2 Oct 2025 (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 objective of this multicentric observational study is to evaluate the prognostic influence of adherence or non-adherence to the recommended coronary angiography timeframe (within 24 hours) and the six-month prognosis of the patients.
Detailed description
Primary Objective: To describe the predictive values (sensitivity and specificity) of the timing of coronary angiography after the diagnosis of NSTEMI.
Secondary Objective: To evaluate an optimal threshold for the timing of coronary angiography that predicts poor prognosis at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) (MACCE = Major Adverse Cardiac and Cerebral Events, stroke = cerebrovascular accident).
Comparisons:
Comparison of severe events at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 6 months (all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, considered separately) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 1 month (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of the occurrence of severe events (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, treated as survival data) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Additional Descriptions:
Description of the prevalence of patients for whom the recommended timing of coronary angiography is followed.
Comparison of the characteristics of patients who underwent coronary angiography within 24 hours versus those who did not (age, LVEF (left ventricular ejection fraction), troponin level, creatinine, NYHA class (New York Heart Association heart failure classification)).
Comparison of the length of hospitalization based on the timing of coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | – | –Invasive coronary angiography within 24 hours after diagnosis |
| Delayed intervention | – | –Invasive coronary angiography more than 24 hours after diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The included patients are those diagnosed with NSTEMI who have undergone coronary angiography as recommended, with no changes to the subsequent patient follow-up
Key inclusion criteria (3 listed)
- Presence of chest pain with or without ECG changes
- Elevation of troponin level > 90th percentile or a significant increase between two dosages
- Significant or non-significant coronary lesion confirming the diagnosis of coronary artery disease on coronary angiography (coronary angiography mandatory before inclusion to confirm NSTEMI)
Key exclusion criteria (8 listed)
- STEMI (ST-segment elevation myocardial infarction) or equivalent (defined as chest pain with ECG changes and troponin elevation > 5 times the normal with an occluded artery (TIMI 0, 1, or 2) during initial coronary angiography)
- Very high-risk NSTEMI (hemodynamic instability, cardiogenic shock, recurrent/refractory chest pain despite optimal medical treatment, life-threatening arrhythmia, mechanical complication, heart failure clearly related to NSTEMI, ST depression > 1mm/6 leads with ST elevation in aVR and/or V1) for which urgent coronary angiography is mandatory
- Unstable angina (acute coronary syndrome without troponin elevation)
- Troponin elevation without chest pain or symptoms suggestive of NSTEMI
- Recovered 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.
Primary outcome
Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months
Time frame: From enrollment to 6 months
Sensibility and specificity, positive and negative predictive values
7 secondary outcomes
Evaluation of the optimal timing of invasive coronary angiography predicting a negative outcome at 6 months
Time frame: From enrollment to 6 months
Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 6 months
Time frame: From enrollment to 6 months
Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 1 month
Time frame: From enrollment to 1 month
Comparison of each element of the composite criteria individually at 6 months of an invasive coronary angiography within 24h and after 24h
Time frame: From enrollment to 6 months
Describe the prevalence of patients receiving an invasive in respect to the timing of the guidelines
Time frame: At enrollment
Comparison of major bleeding at 6 months
Time frame: From enrollment to 6 months
Length of in-patient 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 2 Oct 2025.
- Background: PubMed 20359842Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.
- 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 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.
- Background: PubMed 35514079Kite TA, Kurmani SA, Bountziouka V, Cooper NJ, Lock ST, Gale CP, Flather M, Curzen N, Banning AP, McCann GP, Ladwiniec A. Timing of invasive strategy in non-ST-elevation acute coronary syndrome: a meta-analysis of randomized controlled trials. Eur Heart J. 2022 Sep 1;43(33):3148-3161. doi: 10.1093/eurheartj/ehac213.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NSTEMI and NSTE-ACS (NSTEMI and UA), 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 3 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 2 Oct 2025. 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?
Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months (time frame: From enrollment to 6 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 NCT07204847, which also lists 4 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 Oct 2025.