Chronic Coronary Syndromeτ-icECGNCT05583786
Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia
An observational study of Chronic Coronary Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study evaluates a new diagnostic approach based on intracoronary electrocardiogram (icECG) ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Tracing intracoronary electrocardiogram
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2022to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic coronary syndrome electively referred to the investigators department for coronary angiography.
Who may be able to join
- Chronic coronary syndrome
- Chronic stable 1-3 vessel coronary artery disease
- Coronary stenotic lesion of any diameter narrowing
- Age > 18 years
- Referred for elective coronary angiography to the investigators institution
- Written informed consent to participate in the study
Who cannot join
- Acute coronary syndrome
- Unstable cardiopulmonary condition
- Severe aortic valve stenosis
- Acute congestive heart failure NYHA (New York Heart Association) III-IV
- ECG bundle branch blocks, non-sinus rhythm or paced rhythm
- Coronary anatomy unsuitable for coronary measurements
- Severe pulmonary, renal or hepatic disease
- Women of childbearing age (≤50years and ≤12months after the last menstruation)
Trial locations and contacts
1 site in 1 country.
Andrea K Kieninger-Gräfitsch, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern, 3010
Andrea K Kieninger-Graefitsch, MD, +41 31 632 21 11 ext. 5670, andrea.kieninger-graefitsch@insel.ch
Jonas Häner, MD
About this study
Official title: Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia, τ-icECG: a New Method for Assessing Hemodynamic Stenosis Severity
This study evaluates a new diagnostic approach based on intracoronary electrocardiogram (icECG) ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.
Read the detailed description
Cardiovascular disease is the major cause of death globally, accounting for 17.9 million deaths per year in 2019. Aside from the acute coronary syndrome, where percutaneous coronary intervention (PCI) has been shown to improve outcome, the number of patients with chronic coronary syndrome (CCS) is also increasing. PCI of hemodynamically relevant stenotic lesions causing myocardial ischemia is the standard treatment in these patients. Effective revascularization, as recommended by the European Society of Cardiology (ESC) guidelines, requires to differentiate between hemodynamically relevant and non-significant stenotic coronary lesions.
Currently, coronary stenosis assessment is performed by structural visual angiographic assessment or by coronary pressure measurements up- and downstream of the lesion. The latter is recommended by the ESC and is based on its prognostic value derived from large randomized clinical trials. Given temporary paralysis of the coronary microcirculation by a hyperemia-inducing substance such as adenosine (ADO), pressure is, in theory, directly related to coronary flow. Therefore, the pressure drop during hyperemia across a coronary stenosis, i.e., fractional flow reserve (FFR) provides an estimate of its restrictive effect on flow. However, this method depends on expensive pressure sensor angioplasty guidewires, and on hyperemia-inducing substances, such as ADO. Hence, pharmacologic limitations such as atrioventricular conduction defects and asthma and other potential adverse events (e.g. arrhythmias) aside from costs are major drawbacks of pressure-derived FFR. In order to avoid potential drug-induced side effects and achieve maximal hyperemia, the study group performs reactive hyperemia FFR measurements induced by a proximal, 1-minute coronary artery balloon occlusion. This method has been documented non-inferior in its ability to detect relevant coronary stenosis compared to adenosine-induced FFR.
The present project aims at validating a novel, potentially more harmless, faster and less costly diagnostic approach for measuring hemodynamic coronary stenosis severity.
The commonly obtained surface lead electrocardiogram (ECG) is limited in detecting short-lasting or minor myocardial ischemia. In comparison, intracoronary ECG (icECG) is more time- and space-sensitive in detecting myocardial ischemia, the latter being due to its close vicinity to the myocardial region of interest. It can be easily obtained by attaching an alligator clamp to a coronary guidewire.
Based on the sensitivity of the icECG, several clinical trials have assessed the value of icECG to guide PCI, and rated it useful to predict post-procedural myocardial injury.
The investigators research group performed a trial to determine the diagnostic accuracy of icECG ST-segment shift during pharmacologic inotropic stress in assessing functional coronary lesion severity versus structural stenosis severity as obtained by quantitative coronary angiography in % diameter narrowing (%S by QCA), and versus other functional hemodynamic indices (FFR, instantaneous wave-free ratio (iFR)). IcECG ST-segment shift showed a significant correlation with all established parameters.
Evaluation of icECG required the development of a specific software algorithm, which robustly determines quantitative icECG ST-segment shift in every single heartbeat. The validation analysis of the algorithm took place in an offline setting and demonstrated an excellent correlation as compared to the results of ECG experts (r2 = 0.932; p<0.001).
The development of this fully autonomous icECG analyzing algorithm was set up on an existing ECG software, denoted as "EsoLive", developed at the Institute for Medical Engineering and Medical Informatics, University of Applied Sciences and Arts Northwestern Switzerland. In short, the algorithm starts with a baseline wander extraction method related to Kalman filtering, then sets the initial points for an "edge", i.e., J-point, before, it processes in a similar way the isoelectric line level. Quantitative time as well as voltage measurements of those two points allow the calculation of the icECG ST-segment shift for each single QRS complex.
This study evaluates a new diagnostic approach based on icECG ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Tracing intracoronary electrocardiogram
- Keywords
- Intracoronary electrocardiogram, icECG, Reactive-hyperemia, Balloon occlusion, Fractional flow ratio, FFR
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracing intracoronary electrocardiogramDiagnostic test
icECG ST-segment shift remission time (τ-icECG) tracing during reactive-hyperemia, obtained immediately after a 1-minute upstream coronary artery balloon occlusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
icECG ST-segment shift remission time (τ-icECG)
The primary study objective is to test reactive hyperemia τ-icECG as obtained immediately after a 1-minute upstream coronary artery balloon occlusion as a new method to determine the hemodynamic significance of a coronary artery stenosis. As primary reference method, reactive hyperemia FFR (cut-off 0.80) is employed.
Measured: once after a 1-minute coronary ballon occlusion
Secondary outcomes (3)
Quantitative percent diameter narrowing (secondary reference) (%S)
The secondary study objective is to test reactive hyperemia τ-icECG against the structural reference of a coronary artery stenosis, %S, and to compare the accuracy of τ-icECG against reactive hyperemia FFR, and instantaneous wave-free ratio (iFR).
Measured: once after a 1-minute coronary ballon occlusion
Reactive hyperemia FFR (primary reference)
The secondary study objective is to compare the accuracy of τ-icECG against reactive hyperemia FFR.
Measured: once after a 1-minute coronary ballon occlusion
Instantaneous wave-free ratio (iFR)
The secondary study objective is to compare the accuracy of τ-icECG against iFR.
Measured: once before a 1-minute coronary ballon occlusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jun 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Seiler, Prof, Principal investigator, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583786
- Sponsor's protocol ID
- 2022-00522
- Acronym
- τ-icECG
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, Widimsky P, McCullough PA, Hunt D, Braunwald E, Yusuf S. Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005 Jun 15;293(23):2908-17. doi: 10.1001/jama.293.23.2908.
PubMed 15956636Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
PubMed 23996286Stegehuis VE, Wijntjens GW, Piek JJ, van de Hoef TP. Fractional Flow Reserve or Coronary Flow Reserve for the Assessment of Myocardial Perfusion : Implications of FFR as an Imperfect Reference Standard for Myocardial Ischemia. Curr Cardiol Rep. 2018 Jul 26;20(9):77. doi: 10.1007/s11886-018-1017-4.
PubMed 30046914Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
PubMed 8637515Piccolo R, Niglio T, Di Gioia G, D'Anna C, De Rosa R, Strisciuglio T, Trimarco B, Piscione F, Galasso G. Adenosine-induced torsade de pointes complicating a fractional flow reserve measurement in a right coronary artery intermediate stenosis. Cardiovasc Revasc Med. 2013 Mar-Apr;14(2):118-20. doi: 10.1016/j.carrev.2012.12.010. Epub 2013 Feb 19.
PubMed 23433828Stoller M, Seiler C. Reactive myocardial hyperaemia for functional assessment of coronary stenosis severity. EuroIntervention. 2017 Jun 2;13(2):e201-e209. doi: 10.4244/EIJ-D-16-00579.
PubMed 27993753Friedman PL, Shook TL, Kirshenbaum JM, Selwyn AP, Ganz P. Value of the intracoronary electrocardiogram to monitor myocardial ischemia during percutaneous transluminal coronary angioplasty. Circulation. 1986 Aug;74(2):330-9. doi: 10.1161/01.cir.74.2.330.
PubMed 2942314Pande AK, Meier B, Urban P, Moles V, Dorsaz PA, Favre J. Intracoronary electrocardiogram during coronary angioplasty. Am Heart J. 1992 Aug;124(2):337-41. doi: 10.1016/0002-8703(92)90595-m.
PubMed 1636577Hishikari K, Yonetsu T, Lee T, Koura K, Murai T, Iwai T, Takagi T, Isobe M, Iesaka Y, Kakuta T. Intracoronary electrocardiogram ST-segment elevation in patients with non-ST-segment elevation myocardial infarction and its association with culprit lesion location and myocardial injury. EuroIntervention. 2014 May;10(1):105-12. doi: 10.4244/EIJV10I1A17.
PubMed 24048173Balian V, Galli M, Marcassa C, Cecchin G, Child M, Barlocco F, Petrucci E, Filippini G, Michi R, Onofri M. Intracoronary ST-segment shift soon after elective percutaneous coronary intervention accurately predicts periprocedural myocardial injury. Circulation. 2006 Oct 31;114(18):1948-54. doi: 10.1161/CIRCULATIONAHA.106.620476. Epub 2006 Oct 23.
PubMed 17060382Bigler MR, Stoller M, Praz F, Siontis GCM, Grossenbacher R, Tschannen C, Seiler C. Functional assessment of myocardial ischaemia by intracoronary ECG. Open Heart. 2021 Jan;8(1):e001447. doi: 10.1136/openhrt-2020-001447.
PubMed 33462106
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia, τ-icECG: a New Method for Assessing Hemodynamic Stenosis Severity
- ClinicalTrials.gov ID
- NCT05583786
- Acronym / sponsor ID
- τ-icECG / 2022-00522
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Intracoronary electrocardiogram, icECG, Reactive-hyperemia, Balloon occlusion, Fractional flow ratio, FFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 18 Oct 2022 (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.
This study evaluates a new diagnostic approach based on intracoronary electrocardiogram (icECG) ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.
Detailed description
Cardiovascular disease is the major cause of death globally, accounting for 17.9 million deaths per year in 2019. Aside from the acute coronary syndrome, where percutaneous coronary intervention (PCI) has been shown to improve outcome, the number of patients with chronic coronary syndrome (CCS) is also increasing. PCI of hemodynamically relevant stenotic lesions causing myocardial ischemia is the standard treatment in these patients. Effective revascularization, as recommended by the European Society of Cardiology (ESC) guidelines, requires to differentiate between hemodynamically relevant and non-significant stenotic coronary lesions.
Currently, coronary stenosis assessment is performed by structural visual angiographic assessment or by coronary pressure measurements up- and downstream of the lesion. The latter is recommended by the ESC and is based on its prognostic value derived from large randomized clinical trials. Given temporary paralysis of the coronary microcirculation by a hyperemia-inducing substance such as adenosine (ADO), pressure is, in theory, directly related to coronary flow. Therefore, the pressure drop during hyperemia across a coronary stenosis, i.e., fractional flow reserve (FFR) provides an estimate of its restrictive effect on flow. However, this method depends on expensive pressure sensor angioplasty guidewires, and on hyperemia-inducing substances, such as ADO. Hence, pharmacologic limitations such as atrioventricular conduction defects and asthma and other potential adverse events (e.g. arrhythmias) aside from costs are major drawbacks of pressure-derived FFR. In order to avoid potential drug-induced side effects and achieve maximal hyperemia, the study group performs reactive hyperemia FFR measurements induced by a proximal, 1-minute coronary artery balloon occlusion. This method has been documented non-inferior in its ability to detect relevant coronary stenosis compared to adenosine-induced FFR.
The present project aims at validating a novel, potentially more harmless, faster and less costly diagnostic approach for measuring hemodynamic coronary stenosis severity.
The commonly obtained surface lead electrocardiogram (ECG) is limited in detecting short-lasting or minor myocardial ischemia. In comparison, intracoronary ECG (icECG) is more time- and space-sensitive in detecting myocardial ischemia, the latter being due to its close vicinity to the myocardial region of interest. It can be easily obtained by attaching an alligator clamp to a coronary guidewire.
Based on the sensitivity of the icECG, several clinical trials have assessed the value of icECG to guide PCI, and rated it useful to predict post-procedural myocardial injury.
The investigators research group performed a trial to determine the diagnostic accuracy of icECG ST-segment shift during pharmacologic inotropic stress in assessing functional coronary lesion severity versus structural stenosis severity as obtained by quantitative coronary angiography in % diameter narrowing (%S by QCA), and versus other functional hemodynamic indices (FFR, instantaneous wave-free ratio (iFR)). IcECG ST-segment shift showed a significant correlation with all established parameters.
Evaluation of icECG required the development of a specific software algorithm, which robustly determines quantitative icECG ST-segment shift in every single heartbeat. The validation analysis of the algorithm took place in an offline setting and demonstrated an excellent correlation as compared to the results of ECG experts (r2 = 0.932; p<0.001).
The development of this fully autonomous icECG analyzing algorithm was set up on an existing ECG software, denoted as "EsoLive", developed at the Institute for Medical Engineering and Medical Informatics, University of Applied Sciences and Arts Northwestern Switzerland. In short, the algorithm starts with a baseline wander extraction method related to Kalman filtering, then sets the initial points for an "edge", i.e., J-point, before, it processes in a similar way the isoelectric line level. Quantitative time as well as voltage measurements of those two points allow the calculation of the icECG ST-segment shift for each single QRS complex.
This study evaluates a new diagnostic approach based on icECG ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic coronary syndrome electively referred to the investigators department for coronary angiography.
Key inclusion criteria (6 listed)
- Chronic coronary syndrome
- Chronic stable 1-3 vessel coronary artery disease
- Coronary stenotic lesion of any diameter narrowing
- Age > 18 years
- Referred for elective coronary angiography to the investigators institution
Key exclusion criteria (8 listed)
- Acute coronary syndrome
- Unstable cardiopulmonary condition
- Severe aortic valve stenosis
- Acute congestive heart failure NYHA (New York Heart Association) III-IV
- ECG bundle branch blocks, non-sinus rhythm or paced rhythm
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 |
|---|---|---|
| Tracing intracoronary electrocardiogramicECG ST-segment shift remission time (τ-icECG) tracing during reactive-hyperemia, obtained immediately after a 1-minute upstream coronary artery balloon occlusion. | Diagnostic test | – |
Primary outcome
icECG ST-segment shift remission time (τ-icECG)
Time frame: once after a 1-minute coronary ballon occlusion
The primary study objective is to test reactive hyperemia τ-icECG as obtained immediately after a 1-minute upstream coronary artery balloon occlusion as a new method to determine the hemodynamic significance of a coronary artery stenosis. As primary reference method, reactive hyperemia FFR (cut-off 0.80) is employed.
3 secondary outcomes
Quantitative percent diameter narrowing (secondary reference) (%S)
Time frame: once after a 1-minute coronary ballon occlusion
Reactive hyperemia FFR (primary reference)
Time frame: once after a 1-minute coronary ballon occlusion
Instantaneous wave-free ratio (iFR)
Time frame: once before a 1-minute coronary ballon occlusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Background: PubMed 15956636Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, Widimsky P, McCullough PA, Hunt D, Braunwald E, Yusuf S. Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005 Jun 15;293(23):2908-17. doi: 10.1001/jama.293.23.2908.
- Background: PubMed 23996286Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
- Background: PubMed 30046914Stegehuis VE, Wijntjens GW, Piek JJ, van de Hoef TP. Fractional Flow Reserve or Coronary Flow Reserve for the Assessment of Myocardial Perfusion : Implications of FFR as an Imperfect Reference Standard for Myocardial Ischemia. Curr Cardiol Rep. 2018 Jul 26;20(9):77. doi: 10.1007/s11886-018-1017-4.
- Background: PubMed 8637515Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
- Background: PubMed 23433828Piccolo R, Niglio T, Di Gioia G, D'Anna C, De Rosa R, Strisciuglio T, Trimarco B, Piscione F, Galasso G. Adenosine-induced torsade de pointes complicating a fractional flow reserve measurement in a right coronary artery intermediate stenosis. Cardiovasc Revasc Med. 2013 Mar-Apr;14(2):118-20. doi: 10.1016/j.carrev.2012.12.010. Epub 2013 Feb 19.
- Background: PubMed 27993753Stoller M, Seiler C. Reactive myocardial hyperaemia for functional assessment of coronary stenosis severity. EuroIntervention. 2017 Jun 2;13(2):e201-e209. doi: 10.4244/EIJ-D-16-00579.
- Background: PubMed 2942314Friedman PL, Shook TL, Kirshenbaum JM, Selwyn AP, Ganz P. Value of the intracoronary electrocardiogram to monitor myocardial ischemia during percutaneous transluminal coronary angioplasty. Circulation. 1986 Aug;74(2):330-9. doi: 10.1161/01.cir.74.2.330.
- Background: PubMed 1636577Pande AK, Meier B, Urban P, Moles V, Dorsaz PA, Favre J. Intracoronary electrocardiogram during coronary angioplasty. Am Heart J. 1992 Aug;124(2):337-41. doi: 10.1016/0002-8703(92)90595-m.
- Background: PubMed 24048173Hishikari K, Yonetsu T, Lee T, Koura K, Murai T, Iwai T, Takagi T, Isobe M, Iesaka Y, Kakuta T. Intracoronary electrocardiogram ST-segment elevation in patients with non-ST-segment elevation myocardial infarction and its association with culprit lesion location and myocardial injury. EuroIntervention. 2014 May;10(1):105-12. doi: 10.4244/EIJV10I1A17.
- Background: PubMed 17060382Balian V, Galli M, Marcassa C, Cecchin G, Child M, Barlocco F, Petrucci E, Filippini G, Michi R, Onofri M. Intracoronary ST-segment shift soon after elective percutaneous coronary intervention accurately predicts periprocedural myocardial injury. Circulation. 2006 Oct 31;114(18):1948-54. doi: 10.1161/CIRCULATIONAHA.106.620476. Epub 2006 Oct 23.
- Background: PubMed 33462106Bigler MR, Stoller M, Praz F, Siontis GCM, Grossenbacher R, Tschannen C, Seiler C. Functional assessment of myocardial ischaemia by intracoronary ECG. Open Heart. 2021 Jan;8(1):e001447. doi: 10.1136/openhrt-2020-001447.
- Individual participant dataSharing planned: No
Related trials for Chronic Coronary Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruiting
Shiwei Anshen Granules for Chronic Insomnia
Chronic Insomnia
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
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.
Andrea K Kieninger-Gräfitsch, MD contact
Christian Seiler, Prof principal investigator
Inselspital
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 Chronic Coronary Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Oct 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea K Kieninger-Gräfitsch, MD (+41 31 632 21 11 ext. 5670, andrea.kieninger-graefitsch@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
icECG ST-segment shift remission time (τ-icECG) (time frame: once after a 1-minute coronary ballon occlusion). 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 NCT05583786, which also lists 11 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 21 Oct 2022.