Non ST Elevation Acute Coronary SyndromesAPACHENCT02748603
Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
An observational study of Non ST Elevation Acute Coronary Syndromes and Stable Coronary Syndromes, run by Italian Society of Invasive Cardiology at 1 site in Italy.
Trial summary
An observational, retrospective, multicenter, blinded adjudication study to evaluate the clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary syndrome without ST-segment elevation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non ST Elevation Acute Coronary Syndromes, Stable Coronary Syndromes, NSTEMI
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twenty patients per center will be selected among those who underwent PCI in the last months, going backwards from the date of first Site visit. Selection will be stratified for clinical presentation in two subgroups (stable CAD:NSTEACS = 4:1) and diabetes status (1:1) for each subgroups.
Who may be able to join
- Age >= 18 yrs
- Stable Coronary Artery Disease(CAD)
- Unstable Angina or NSTEMI
Who cannot join
- STEMI at presentation
- previous CABG
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico S. Matteo
Pavia, Pv, 27100
About this study
An observational, retrospective, multicenter, blinded adjudication study to evaluate the clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included patients will be diabetic. Also the implementation of selected, key guideline recommendations will be examined.
At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories in Italy in the region of Lombardia and Veneto.
This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and all applicable regulatory requirements.
Read the detailed description
A strategy based on early invasive coronary angiography followed by revascularization is the most effective treatment of patients with acute coronary syndrome, especially in those with ST-segment elevation (STE-ACS). In patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS), an early invasive strategy is associated with a reduction in cardiac death and myocardial infarction in patients at higher risk. In stable coronary artery disease rather no data so convincing. The undeniable evolution of techniques of PCI has been accompanied by a parallel progress of medical therapy and also from increased awareness, both cardiologists and patients, the importance of the control of coronary risk factors.
European Society of Cardiology Guide give precise indications (but often ignored) on the use of PCI or coronary artery bypass grafting according to the extent of coronary artery disease and the site of injury . However, especially in patients with NSTE-ACS often we limit ourselves to dilate the culprit stenosis, leaving untreated other injuries that underlie large myocardial territory, that is, by configuring an incomplete revascularization framework. The calculation of the SYNTAX score residual (that is, what remains after percutaneous revascularization procedure) allows to objectively verify the incompleteness of PCI treatment, which correlates with the outcome in the patient's distance . Moreover, in case of equivocal stenosis, especially in patients with stable coronary disease, large should be the use of a functional assessment using the calculation of the Fractional Flow Reserve (FFR).
This could indicate that the increase of the number of invasive diagnostic tests does not increase the number of patients with coronary artery disease extended, in which is usually indicated a surgical revascularization. So to identify patients at higher risk, may be enough specific investigations and conducted selectively.
The purpose of the pilot study APACHE is to assess the appropriateness of indication and appropriateness of execution of a sample carried out PCI in patients with stable coronary artery disease and in patients with NSTE-ACS (in the ratio 4: 1). As such, the APACHE be considered a quality improvement initiative.
Retrospective observational study, multicenter. The study population will consist of 20 cases of PCI per center (then about 400 PCI in total) selected randomly within the center of the case studies in the previous approval of the study. Of these 16 will be patients with stable coronary artery disease (including 8 with diabetes mellitus in medical therapy) and 4 will be patients with NSTE-ACS (4: 1 ratio).
Patients with a history of coronary artery bypass are excluded. The series will consist of patients in whom the procedure was carried out in the previous year to a declaration of participation in the survey and in any case after the publication of the document. There have been no previous analysis of this type in Italy and is therefore not known what is the rate of inappropriateness for PCI procedures in stable patients. It is not possible therefore to perform a calculation of sample size. However, the investigators believes that for a pilot analysis, an initial sample of 400 PCI procedures, analytically considered, is sufficient to verify the magnitude of the problem in the Italian Catheterization Laboratories.
The investigators anticipate the participation of about 20 centers in total between Lombardia and Veneto italian regions. The study will have an approximate duration of about 2 years.
The data to be collected will be different in patients with nSTE - ACS compared to patients with stable coronary artery disease. As an initiative of quality improvement, and according to extensive international literature on the subject, will not be requested individual informed consent to selected patients but only the approval of the Ethics Committee of the Center Coordinator. Patient data will be de-identified and used only in the aggregate and all individual sensitive information (name, phone, address) will be erased.
- Conditions
- Non ST Elevation Acute Coronary Syndromes, Stable Coronary Syndromes, NSTEMI, Unstable Angina
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable
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 |
|---|---|---|
| Patient with non ST Elevation - Acute Coronary Syndrome | Not described | |
| Patient with stable Coronary Artery Disease (CAD) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with stable Coronary Artery Disease (CAD) whose clinical indication was appropriate for the treatment with Percutaneous Coronary Intervention (PCI).
Appropriateness will be defined by a final score of ≥ 7 of the Central Heart Team according to appropriate use criteria.
Measured: 3 months
Secondary outcomes (8)
Proportion of patients with complex lesions (left main, proximal LAD, three-vessel disease) treated ad hoc without documentation of Heart Team discussion in the medical records with stable CAD.
Measured: 3 months
Proportion of patients receiving incomplete revascularization (i.e. residual SYNTAX > 8)Heart Team or in patients without documented ischemia with stable CAD.
Measured: 3 months
Proportion of patients receiving guideline-recommended medical therapy at the time of PCI with stable CAD.
Measured: 3 months
Incidence of FFR-guided PCI for stenosis of uncertain significance according to the Central Heart Team or in patients without documented ischemia with stable CAD.
Measured: 3 months
Proportion of patients who received PCI but with an indication for CABG according to guidelines and no Heart team discussion in the medical record with stable CAD.
Measured: 3 months
Proportion of patients treated with PCI whose clinical indication appears appropriate defined by a final score of ≥ 7 of the Heart Team according to appropriate use criteria for Non ST elevation ACS (nSTE-ACS).
Measured: 3 months
Proportion of PCI procedures performed within 24 hours of admission in patients with nSTEACS with GRACE> 140 for nSTE-ACS.
Measured: 3 months
Proportion of patients with nSTEACS who are stabilized (no recurrent ischemic symptoms) who have multivessel disease and a high SYNTAX score (>22), without documentation of Heart Team discussion in the medical records for nSTE-ACS.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
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 Non ST Elevation Acute Coronary SyndromesStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Society of Invasive Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
- Investigators
- Stefano De Servi, MD, Study chair, Fondazione IRCCS Policlinico San Matteo di PaviaSergio Leonardi, MD, Study director, IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748603
- Sponsor's protocol ID
- 20140003325
- Acronym
- APACHE
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucas FL, Siewers AE, Malenka DJ, Wennberg DE. Diagnostic-therapeutic cascade revisited: coronary angiography, coronary artery bypass graft surgery, and percutaneous coronary intervention in the modern era. Circulation. 2008 Dec 16;118(25):2797-802. doi: 10.1161/CIRCULATIONAHA.108.789446. Epub 2008 Dec 8.
PubMed 19064681Bauer T, Mollmann H, Weidinger F, Zeymer U, Seabra-Gomes R, Eberli F, Serruys P, Vahanian A, Silber S, Wijns W, Hochadel M, Nef HM, Hamm CW, Marco J, Gitt AK. Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina. Int J Cardiol. 2011 Sep 1;151(2):164-9. doi: 10.1016/j.ijcard.2010.05.006. Epub 2010 Jun 3.
PubMed 20605241Genereux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol. 2012 Jun 12;59(24):2165-74. doi: 10.1016/j.jacc.2012.03.010. Epub 2012 Apr 4.
PubMed 22483327Coronary Revascularization Writing Group; Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; Technical Panel; Masoudi FA, Dehmer GJ, Patel MR, Smith PK, Chambers CE, Ferguson TB Jr, Garcia MJ, Grover FL, Holmes DR Jr, Klein LW, Limacher MC, Mack MJ, Malenka DJ, Park MH, Ragosta M 3rd, Ritchie JL, Rose GA, Rosenberg AB, Russo AM, Shemin RJ, Weintraub WS; Appropriate Use Criteria Task Force; Wolk MJ, Bailey SR, Douglas PS, Hendel RC, Kramer CM, Min JK, Patel MR, Shaw L, Stainback RF, Allen JM; American College of Cardiology Foundation; American College of Cardiology Foundation Appropriate Use Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Thoracic Surgery; American Heart Association; American Society of Nuclear Cardiology; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Thorac Cardiovasc Surg. 2012 Apr;143(4):780-803. doi: 10.1016/j.jtcvs.2012.01.061.
PubMed 22424518Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med. 2008 Feb 21;358(8):765-7. doi: 10.1056/NEJMp0800136. No abstract available.
PubMed 18287598Dauerman HL. Reasonable incomplete revascularization. Circulation. 2011 May 31;123(21):2337-40. doi: 10.1161/CIRCULATIONAHA.111.033126. Epub 2011 May 16. No abstract available.
PubMed 21576647Leonardi S, Marino M, Crimi G, Maiorana F, Rizzotti D, Lettieri C, Bettari L, Zuccari M, Sganzerla P, Tresoldi S, Adamo M, Ghiringhelli S, Sponzilli C, Pasquetto G, Pavei A, Pedon L, Bassan L, Bollati M, Camisasca P, Trabattoni D, Brancati M, Poli A, Panciroli C, Lettino M, Tarelli G, Tarantini G, De Luca L, Varbella F, Musumeci G, De Servi S. APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study. BMJ Open. 2017 Sep 5;7(9):e016909. doi: 10.1136/bmjopen-2017-016909.
PubMed 28877948
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
- ClinicalTrials.gov ID
- NCT02748603
- Acronym / sponsor ID
- APACHE / 20140003325
- Conditions
- Non ST Elevation Acute Coronary Syndromes, Stable Coronary Syndromes, NSTEMI, Unstable Angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Italian Society of Invasive CardiologyUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- Oct 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- 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.
An observational, retrospective, multicenter, blinded adjudication study to evaluate the clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included patients will be diabetic. Also the implementation of selected, key guideline recommendations will be examined.
At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories in Italy in the region of Lombardia and Veneto.
This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and all applicable regulatory requirements.
Detailed description
A strategy based on early invasive coronary angiography followed by revascularization is the most effective treatment of patients with acute coronary syndrome, especially in those with ST-segment elevation (STE-ACS). In patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS), an early invasive strategy is associated with a reduction in cardiac death and myocardial infarction in patients at higher risk. In stable coronary artery disease rather no data so convincing. The undeniable evolution of techniques of PCI has been accompanied by a parallel progress of medical therapy and also from increased awareness, both cardiologists and patients, the importance of the control of coronary risk factors.
European Society of Cardiology Guide give precise indications (but often ignored) on the use of PCI or coronary artery bypass grafting according to the extent of coronary artery disease and the site of injury . However, especially in patients with NSTE-ACS often we limit ourselves to dilate the culprit stenosis, leaving untreated other injuries that underlie large myocardial territory, that is, by configuring an incomplete revascularization framework. The calculation of the SYNTAX score residual (that is, what remains after percutaneous revascularization procedure) allows to objectively verify the incompleteness of PCI treatment, which correlates with the outcome in the patient's distance . Moreover, in case of equivocal stenosis, especially in patients with stable coronary disease, large should be the use of a functional assessment using the calculation of the Fractional Flow Reserve (FFR).
This could indicate that the increase of the number of invasive diagnostic tests does not increase the number of patients with coronary artery disease extended, in which is usually indicated a surgical revascularization. So to identify patients at higher risk, may be enough specific investigations and conducted selectively.
The purpose of the pilot study APACHE is to assess the appropriateness of indication and appropriateness of execution of a sample carried out PCI in patients with stable coronary artery disease and in patients with NSTE-ACS (in the ratio 4: 1). As such, the APACHE be considered a quality improvement initiative.
Retrospective observational study, multicenter. The study population will consist of 20 cases of PCI per center (then about 400 PCI in total) selected randomly within the center of the case studies in the previous approval of the study. Of these 16 will be patients with stable coronary artery disease (including 8 with diabetes mellitus in medical therapy) and 4 will be patients with NSTE-ACS (4: 1 ratio).
Patients with a history of coronary artery bypass are excluded. The series will consist of patients in whom the procedure was carried out in the previous year to a declaration of participation in the survey and in any case after the publication of the document. There have been no previous analysis of this type in Italy and is therefore not known what is the rate of inappropriateness for PCI procedures in stable patients. It is not possible therefore to perform a calculation of sample size. However, the investigators believes that for a pilot analysis, an initial sample of 400 PCI procedures, analytically considered, is sufficient to verify the magnitude of the problem in the Italian Catheterization Laboratories.
The investigators anticipate the participation of about 20 centers in total between Lombardia and Veneto italian regions. The study will have an approximate duration of about 2 years.
The data to be collected will be different in patients with nSTE - ACS compared to patients with stable coronary artery disease. As an initiative of quality improvement, and according to extensive international literature on the subject, will not be requested individual informed consent to selected patients but only the approval of the Ethics Committee of the Center Coordinator. Patient data will be de-identified and used only in the aggregate and all individual sensitive information (name, phone, address) will be erased.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with non ST Elevation - Acute Coronary Syndrome | – | – |
| Patient with stable Coronary Artery Disease (CAD) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty patients per center will be selected among those who underwent PCI in the last months, going backwards from the date of first Site visit. Selection will be stratified for clinical presentation in two subgroups (stable CAD:NSTEACS = 4:1) and diabetes status (1:1) for each subgroups.
Key inclusion criteria (3 listed)
- Age >= 18 yrs
- Stable Coronary Artery Disease(CAD)
- Unstable Angina or NSTEMI
Key exclusion criteria (2 listed)
- STEMI at presentation
- previous CABG
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
Proportion of patients with stable Coronary Artery Disease (CAD) whose clinical indication was appropriate for the treatment with Percutaneous Coronary Intervention (PCI).
Time frame: 3 months
Appropriateness will be defined by a final score of ≥ 7 of the Central Heart Team according to appropriate use criteria.
8 secondary outcomes
Proportion of patients with complex lesions (left main, proximal LAD, three-vessel disease) treated ad hoc without documentation of Heart Team discussion in the medical records with stable CAD.
Time frame: 3 months
Proportion of patients receiving incomplete revascularization (i.e. residual SYNTAX > 8)Heart Team or in patients without documented ischemia with stable CAD.
Time frame: 3 months
Proportion of patients receiving guideline-recommended medical therapy at the time of PCI with stable CAD.
Time frame: 3 months
Incidence of FFR-guided PCI for stenosis of uncertain significance according to the Central Heart Team or in patients without documented ischemia with stable CAD.
Time frame: 3 months
Proportion of patients who received PCI but with an indication for CABG according to guidelines and no Heart team discussion in the medical record with stable CAD.
Time frame: 3 months
Proportion of patients treated with PCI whose clinical indication appears appropriate defined by a final score of ≥ 7 of the Heart Team according to appropriate use criteria for Non ST elevation ACS (nSTE-ACS).
Time frame: 3 months
Proportion of PCI procedures performed within 24 hours of admission in patients with nSTEACS with GRACE> 140 for nSTE-ACS.
Time frame: 3 months
Proportion of patients with nSTEACS who are stabilized (no recurrent ischemic symptoms) who have multivessel disease and a high SYNTAX score (>22), without documentation of Heart Team discussion in the medical records for nSTE-ACS.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Results publication: PubMed 19064681Lucas FL, Siewers AE, Malenka DJ, Wennberg DE. Diagnostic-therapeutic cascade revisited: coronary angiography, coronary artery bypass graft surgery, and percutaneous coronary intervention in the modern era. Circulation. 2008 Dec 16;118(25):2797-802. doi: 10.1161/CIRCULATIONAHA.108.789446. Epub 2008 Dec 8.
- Results publication: PubMed 20605241Bauer T, Mollmann H, Weidinger F, Zeymer U, Seabra-Gomes R, Eberli F, Serruys P, Vahanian A, Silber S, Wijns W, Hochadel M, Nef HM, Hamm CW, Marco J, Gitt AK. Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina. Int J Cardiol. 2011 Sep 1;151(2):164-9. doi: 10.1016/j.ijcard.2010.05.006. Epub 2010 Jun 3.
- Results publication: PubMed 22483327Genereux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol. 2012 Jun 12;59(24):2165-74. doi: 10.1016/j.jacc.2012.03.010. Epub 2012 Apr 4.
- Results publication: PubMed 22424518Coronary Revascularization Writing Group; Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; Technical Panel; Masoudi FA, Dehmer GJ, Patel MR, Smith PK, Chambers CE, Ferguson TB Jr, Garcia MJ, Grover FL, Holmes DR Jr, Klein LW, Limacher MC, Mack MJ, Malenka DJ, Park MH, Ragosta M 3rd, Ritchie JL, Rose GA, Rosenberg AB, Russo AM, Shemin RJ, Weintraub WS; Appropriate Use Criteria Task Force; Wolk MJ, Bailey SR, Douglas PS, Hendel RC, Kramer CM, Min JK, Patel MR, Shaw L, Stainback RF, Allen JM; American College of Cardiology Foundation; American College of Cardiology Foundation Appropriate Use Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Thoracic Surgery; American Heart Association; American Society of Nuclear Cardiology; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Thorac Cardiovasc Surg. 2012 Apr;143(4):780-803. doi: 10.1016/j.jtcvs.2012.01.061.
- Results publication: PubMed 18287598Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med. 2008 Feb 21;358(8):765-7. doi: 10.1056/NEJMp0800136. No abstract available.
- Results publication: PubMed 21576647Dauerman HL. Reasonable incomplete revascularization. Circulation. 2011 May 31;123(21):2337-40. doi: 10.1161/CIRCULATIONAHA.111.033126. Epub 2011 May 16. No abstract available.
- Derived from this study: PubMed 28877948Leonardi S, Marino M, Crimi G, Maiorana F, Rizzotti D, Lettieri C, Bettari L, Zuccari M, Sganzerla P, Tresoldi S, Adamo M, Ghiringhelli S, Sponzilli C, Pasquetto G, Pavei A, Pedon L, Bassan L, Bollati M, Camisasca P, Trabattoni D, Brancati M, Poli A, Panciroli C, Lettino M, Tarelli G, Tarantini G, De Luca L, Varbella F, Musumeci G, De Servi S. APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study. BMJ Open. 2017 Sep 5;7(9):e016909. doi: 10.1136/bmjopen-2017-016909.
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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.
Stefano De Servi, MD study chair
Fondazione IRCCS Policlinico San Matteo di Pavia
Sergio Leonardi, MD study director
IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center
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 Non ST Elevation Acute Coronary Syndromes and Stable Coronary Syndromes, run by Italian Society of Invasive Cardiology at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. 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 Italy. 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 Florinda Maiorana, DBiotech, PHD (0382982105 ext. CCRC, f.maiorana@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with stable Coronary Artery Disease (CAD) whose clinical indication was appropriate for the treatment with Percutaneous Coronary Intervention (PCI). (time frame: 3 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 NCT02748603, 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 27 Apr 2016.