Chest PainIn-HopeNCT04756362
IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE)
An observational study of Chest Pain and Acute Coronary Syndrome, run by Hospital Samaritano Paulista at 1 site in Brazil.
Trial summary
Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- How many people
- 5,497 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jul 2020to 31 Jul 2022
- 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: Consecutive patients with suspected acute coronary syndrome
Who may be able to join
- Age ≥ 18 years of age
- The patient agrees and signs an informed consent form
- One of the following 2 criteria:
- Acute chest pain (last episode of pain beginning <6 hours after inclusion) or
- Syncope, dyspnea or epigastric pain without an obvious cause at the initial assessment (last episode of one of these symptoms beginning <6 hours after inclusion) associated with at least one of the following factors: Age ≥ 65 years, history of arterial disease, history of diabetes mellitus.
Who cannot join
- Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment
- Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation
- Dialysis patients
- Patients with trauma
- Myocardial revascularization or acute myocardial infarction in the last month
- Pregnant and breastfeeding women
- Patient unable to be followed for 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction With High Sensitivity Troponin T in Different Scenarios (IN-HOspital Program to SystematizE Chest Pain Protocol-IN HOPE)
Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T
Read the detailed description
Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:
- Evaluation of the early exclusion protocol (0 -1 hour) in a Brazilian population
- Evaluation of the early exclusion protocol (0 -1 hour) in isolation and associated with traditional risk scores (TIMI, GRACE, HEART and EDACS)
- Systematic evaluation of the early exclusion protocol (0 -1 hour) in patients without chest pain but with a pre-defined condition of suspected AMI
- Evaluation of the prognostic value of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest pain, Acute coronary syndrome, Troponin
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
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 |
|---|---|---|
| Prospective cohort | A minimum of 294 patients will be included in the evaluation of 0 and 1 hour protocol (prospective evaluation). | |
| Retrospective cohort | A minimum of 1,000 patients will be included in the evaluation of prognostic value of high sensitive cardiac troponin < 5 ng/L(retrospective evaluation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of early rule out for myocardial infarction diagnosis
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours
Measured: 30 days
Secondary outcomes (6)
Accuracy of early rule out for myocardial infarction according to type of symptoms
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours with or without chest pain
Measured: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (TIMI). TIMI score minimum 0 and maximum 7 points (higher scores mean a worse outcome).
Measured: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (EDACS). EDACS score minimum -6 and maximum +20 points (higher scores mean a worse outcome).
Measured: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (GRACE). GRACE score minimum 1 and maximum 372 points (higher scores mean a worse outcome).
Measured: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (HEART). HEART score minimum 0 and maximum 10 points (higher scores mean a worse outcome).
Measured: 30 days
Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.
Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population (retrospective cohort).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start23 Jul 2020
- Primary completion31 Jan 2022
- Study completion31 Jul 2022
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 Chest PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Samaritano Paulista
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Pedro Gabriel Melo de Barros e Silva, Hospital Samaritano Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756362
- Sponsor's protocol ID
- 001/20
- Acronym
- In-Hope
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Barros E Silva PGM, Ferreira AA, Malafaia F, Tavares Reis AFM, Sznejder H, Lopes Junior ACA, Agostinho CA, Fonseca LHO, Okitoi DVD, Correa CM, Zincone E, Cury MP, Rosa GAL, Ribeiro HB, Soeiro AM, de Oliveira CAL, Kuusberg GC, Ohe LN, Souza DO, Manfredi AB, Martins AF, Sampaio PPN, Vaz TB, Franco LF, Ferreira CEDS, Lopes RD; IN-HOPE Investigators. Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):755-764. doi: 10.1093/ehjacc/zuad082.
PubMed 37450613
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction With High Sensitivity Troponin T in Different Scenarios (IN-HOspital Program to SystematizE Chest Pain Protocol-IN HOPE)
- ClinicalTrials.gov ID
- NCT04756362
- Acronym / sponsor ID
- In-Hope / 001/20
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest pain, Acute coronary syndrome, Troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,497 participants (actual)
- Lead sponsor
- Hospital Samaritano PaulistaUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 16 Feb 2021 (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.
Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T
Detailed description
Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:
- Evaluation of the early exclusion protocol (0 -1 hour) in a Brazilian population
- Evaluation of the early exclusion protocol (0 -1 hour) in isolation and associated with traditional risk scores (TIMI, GRACE, HEART and EDACS)
- Systematic evaluation of the early exclusion protocol (0 -1 hour) in patients without chest pain but with a pre-defined condition of suspected AMI
- Evaluation of the prognostic value of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –A minimum of 294 patients will be included in the evaluation of 0 and 1 hour protocol (prospective evaluation). |
| Retrospective cohort | – | –A minimum of 1,000 patients will be included in the evaluation of prognostic value of high sensitive cardiac troponin < 5 ng/L(retrospective evaluation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with suspected acute coronary syndrome
Key inclusion criteria (5 listed)
- Age ≥ 18 years of age
- The patient agrees and signs an informed consent form
- One of the following 2 criteria:
Key exclusion criteria (7 listed)
- Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment
- Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation
- Dialysis patients
- Patients with trauma
- Myocardial revascularization or acute myocardial infarction in the last month
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
Accuracy of early rule out for myocardial infarction diagnosis
Time frame: 30 days
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours
6 secondary outcomes
Accuracy of early rule out for myocardial infarction according to type of symptoms
Time frame: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)
Time frame: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)
Time frame: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)
Time frame: 30 days
Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)
Time frame: 30 days
Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.
Time frame: 30 days
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 3 Aug 2022.
- Derived from this study: PubMed 37450613de Barros E Silva PGM, Ferreira AA, Malafaia F, Tavares Reis AFM, Sznejder H, Lopes Junior ACA, Agostinho CA, Fonseca LHO, Okitoi DVD, Correa CM, Zincone E, Cury MP, Rosa GAL, Ribeiro HB, Soeiro AM, de Oliveira CAL, Kuusberg GC, Ohe LN, Souza DO, Manfredi AB, Martins AF, Sampaio PPN, Vaz TB, Franco LF, Ferreira CEDS, Lopes RD; IN-HOPE Investigators. Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):755-764. doi: 10.1093/ehjacc/zuad082.
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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 Chest Pain and Acute Coronary Syndrome, run by Hospital Samaritano Paulista at 1 site in Brazil.
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 5 inclusion and 7 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 3 Aug 2022. 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 Brazil. 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?
Accuracy of early rule out for myocardial infarction diagnosis (time frame: 30 days). 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 NCT04756362, 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 3 Aug 2022.