Coronary Chronic Total OcclusionsCARISMA_CTONCT03152825
Stress CMR in Patients With Coronary Chronic Total Occlusions
An observational study of Coronary Chronic Total Occlusions, run by Ospedale San Donato at 1 site in Italy.
Trial summary
A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Chronic Total Occlusions
- What is being tested?
- PCI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2017to May 2023
- How long will I take part?
- 12 Months
- 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: Patient with angiographic evidence of CTO with planned PCI.
Who may be able to join
- Angiographic diagnosis of Coronary Chronic Total Occlusion (TIMI 0 lasting more than 3 months, if known)
- baseline stress CMR
- signed informed consent
Who cannot join
- CMR contraindications
- severe CKD
- contraindications to adenosine or dobutamine
- unable/unwilling to sign informed consent
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan
Silvia Pica, MD
About this study
Official title: Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions
A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of CTO lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. However, due to the higher rate of procedural complications and lower success rate of PCI than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or MI of ~5%/year) and plausibly represent the best target for PCI.
Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability. Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion.
This study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by CMR could identify patients who are more likely to benefit from PCI in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.
- Conditions
- Coronary Chronic Total Occlusions
- Being tested
- PCI
- Keywords
- myocardial ischaemia, myocardial viability, coronary chronic total occlusions, cardiac magnetic resonance, stress CMR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
percutaneous coronary intervention attempt
| Study group | Role | What they receive |
|---|---|---|
| Viable myocardium Group | At least ONE of the following:
1. Late gadolinium enhancement <75%.
2. Improvement in segmental function ≥1 grade during low dose dobutamine Receives: Procedure: PCI | |
| Non-viable myocardium group | At least ONE of the following:
1. Late gadolinium enhancement ≥75%.
2. No improvement in segmental function during low dose dobutamine Receives: Procedure: PCI | |
| Inducible ischaemia group | At least ONE of the following:
* perfusion defect (≥ 1,5 segments) assessed during peak infusion of adenosine or dobutamine
* new wall motion abnormalities or worsening ≥1 grade during peak infusion of dobutamine Receives: Procedure: PCI | |
| Non-inducible ischaemia group | None of conditions qualifying for the "Inducible ischemia group" Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mechanical improvement after PCI
At least ONE of the following:
- Delta ejection fraction ≥ 5%
- Segmental function improvement ≥1 grade
- Delta end-diastolic volume ≥ 10%
- Delta end-systolic volume ≥ 10%
Measured: 12 +/- 3 months
Secondary outcomes (3)
Stress ischaemia improvement after PCI
At least ONE of the following stress CMR (adenosine or dobutamine) findings:
_<1.5 segments perfusion defect
_≥1 grade improvement in segmental wall motion abnormalities
Measured: 12 +/- 3 months
Quality of life assessed by Seattle Angina Questionnaire (SAQ)
Delta SAQ score
Measured: 12+/-3 months
Major cardiovascular events
all-cause death, death for cardiovascular cause, life-threatening arrythmia, hospitalization for heart failure, myocardial infarction, target vessel revascularization
Measured: 12+/- 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start10 May 2017
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Coronary Chronic Total OcclusionsStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Lombardi, Ospedale San Donato
- Investigators
- Massimo Lombardi, MD, Principal investigator, Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152825
- Sponsor's protocol ID
- CARISMA_CTO
- Acronym
- CARISMA_CTO
- Status last verified
- Mar 2021
- First submitted
- 7 May 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stone GW, Kandzari DE, Mehran R, Colombo A, Schwartz RS, Bailey S, Moussa I, Teirstein PS, Dangas G, Baim DS, Selmon M, Strauss BH, Tamai H, Suzuki T, Mitsudo K, Katoh O, Cox DA, Hoye A, Mintz GS, Grube E, Cannon LA, Reifart NJ, Reisman M, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part I. Circulation. 2005 Oct 11;112(15):2364-72. doi: 10.1161/CIRCULATIONAHA.104.481283. No abstract available.
PubMed 16216980Shah PB. Management of coronary chronic total occlusion. Circulation. 2011 Apr 26;123(16):1780-4. doi: 10.1161/CIRCULATIONAHA.110.972802. No abstract available.
PubMed 21518991Baim DS, Kwong RY. Is magnetic resonance image guidance the key to opening chronic total occlusions? Circulation. 2006 Feb 28;113(8):1053-5. doi: 10.1161/CIRCULATIONAHA.105.609263. No abstract available.
PubMed 16505189Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.
PubMed 8362709Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
PubMed 15842978Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13.
PubMed 20388873Cheng AS, Selvanayagam JB, Jerosch-Herold M, van Gaal WJ, Karamitsos TD, Neubauer S, Banning AP. Percutaneous treatment of chronic total coronary occlusions improves regional hyperemic myocardial blood flow and contractility: insights from quantitative cardiovascular magnetic resonance imaging. JACC Cardiovasc Interv. 2008 Feb;1(1):44-53. doi: 10.1016/j.jcin.2007.11.003.
PubMed 19393143Pujadas S, Martin V, Rossello X, Carreras F, Barros A, Leta R, Alomar X, Cinca J, Sabate M, Pons-Llado G. Improvement of myocardial function and perfusion after successful percutaneous revascularization in patients with chronic total coronary occlusion. Int J Cardiol. 2013 Oct 30;169(2):147-52. doi: 10.1016/j.ijcard.2013.08.017. Epub 2013 Aug 15.
PubMed 24120215Christakopoulos GE, Christopoulos G, Carlino M, Jeroudi OM, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani DJ, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Meta-analysis of clinical outcomes of patients who underwent percutaneous coronary interventions for chronic total occlusions. Am J Cardiol. 2015 May 15;115(10):1367-75. doi: 10.1016/j.amjcard.2015.02.038. Epub 2015 Feb 18.
PubMed 25784515Hoebers LP, Claessen BE, Elias J, Dangas GD, Mehran R, Henriques JP. Meta-analysis on the impact of percutaneous coronary intervention of chronic total occlusions on left ventricular function and clinical outcome. Int J Cardiol. 2015;187:90-6. doi: 10.1016/j.ijcard.2015.03.164. Epub 2015 Mar 17.
PubMed 25828320Jang WJ, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-term survival benefit of revascularization compared with medical therapy in patients with coronary chronic total occlusion and well-developed collateral circulation. JACC Cardiovasc Interv. 2015 Feb;8(2):271-279. doi: 10.1016/j.jcin.2014.10.010.
PubMed 25700750Valenti R, Migliorini A, Signorini U, Vergara R, Parodi G, Carrabba N, Cerisano G, Antoniucci D. Impact of complete revascularization with percutaneous coronary intervention on survival in patients with at least one chronic total occlusion. Eur Heart J. 2008 Oct;29(19):2336-42. doi: 10.1093/eurheartj/ehn357. Epub 2008 Aug 5.
PubMed 18682446Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.
PubMed 11078769Selvanayagam JB, Kardos A, Francis JM, Wiesmann F, Petersen SE, Taggart DP, Neubauer S. Value of delayed-enhancement cardiovascular magnetic resonance imaging in predicting myocardial viability after surgical revascularization. Circulation. 2004 Sep 21;110(12):1535-41. doi: 10.1161/01.CIR.0000142045.22628.74. Epub 2004 Sep 7.
PubMed 15353496Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, Klocke FJ, Bonow RO, Kim RJ, Judd RM. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: an imaging study. Lancet. 2003 Feb 1;361(9355):374-9. doi: 10.1016/S0140-6736(03)12389-6.
PubMed 12573373
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT03152825
- Acronym / sponsor ID
- CARISMA_CTO / CARISMA_CTO
- Conditions
- Coronary Chronic Total Occlusions
- Keywords
- myocardial ischaemia, myocardial viability, coronary chronic total occlusions, cardiac magnetic resonance, stress CMR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 15 May 2017 (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.
A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of CTO lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. However, due to the higher rate of procedural complications and lower success rate of PCI than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or MI of ~5%/year) and plausibly represent the best target for PCI.
Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability. Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion.
This study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by CMR could identify patients who are more likely to benefit from PCI in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Viable myocardium Group | – | Procedure: PCIAt least ONE of the following: 1. Late gadolinium enhancement <75%. 2. Improvement in segmental function ≥1 grade during low dose dobutamine |
| Non-viable myocardium group | – | Procedure: PCIAt least ONE of the following: 1. Late gadolinium enhancement ≥75%. 2. No improvement in segmental function during low dose dobutamine |
| Inducible ischaemia group | – | Procedure: PCIAt least ONE of the following: * perfusion defect (≥ 1,5 segments) assessed during peak infusion of adenosine or dobutamine * new wall motion abnormalities or worsening ≥1 grade during peak infusion of dobutamine |
| Non-inducible ischaemia group | – | Procedure: PCINone of conditions qualifying for the "Inducible ischemia group" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with angiographic evidence of CTO with planned PCI.
Key inclusion criteria (3 listed)
- Angiographic diagnosis of Coronary Chronic Total Occlusion (TIMI 0 lasting more than 3 months, if known)
- baseline stress CMR
- signed informed consent
Key exclusion criteria (5 listed)
- CMR contraindications
- severe CKD
- contraindications to adenosine or dobutamine
- unable/unwilling to sign informed consent
- pregnancy
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 |
|---|---|---|
| PCIpercutaneous coronary intervention attempt | Procedure or surgery | Inducible ischaemia group, Non-inducible ischaemia group, Non-viable myocardium group, Viable myocardium Group |
Primary outcome
Left ventricular mechanical improvement after PCI
Time frame: 12 +/- 3 months
At least ONE of the following: * Delta ejection fraction ≥ 5% * Segmental function improvement ≥1 grade * Delta end-diastolic volume ≥ 10% * Delta end-systolic volume ≥ 10%
3 secondary outcomes
Stress ischaemia improvement after PCI
Time frame: 12 +/- 3 months
Quality of life assessed by Seattle Angina Questionnaire (SAQ)
Time frame: 12+/-3 months
Major cardiovascular events
Time frame: 12+/- 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 16216980Stone GW, Kandzari DE, Mehran R, Colombo A, Schwartz RS, Bailey S, Moussa I, Teirstein PS, Dangas G, Baim DS, Selmon M, Strauss BH, Tamai H, Suzuki T, Mitsudo K, Katoh O, Cox DA, Hoye A, Mintz GS, Grube E, Cannon LA, Reifart NJ, Reisman M, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part I. Circulation. 2005 Oct 11;112(15):2364-72. doi: 10.1161/CIRCULATIONAHA.104.481283. No abstract available.
- Background: PubMed 21518991Shah PB. Management of coronary chronic total occlusion. Circulation. 2011 Apr 26;123(16):1780-4. doi: 10.1161/CIRCULATIONAHA.110.972802. No abstract available.
- Background: PubMed 16505189Baim DS, Kwong RY. Is magnetic resonance image guidance the key to opening chronic total occlusions? Circulation. 2006 Feb 28;113(8):1053-5. doi: 10.1161/CIRCULATIONAHA.105.609263. No abstract available.
- Background: PubMed 8362709Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.
- Background: PubMed 15842978Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
- Background: PubMed 20388873Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13.
- Background: PubMed 19393143Cheng AS, Selvanayagam JB, Jerosch-Herold M, van Gaal WJ, Karamitsos TD, Neubauer S, Banning AP. Percutaneous treatment of chronic total coronary occlusions improves regional hyperemic myocardial blood flow and contractility: insights from quantitative cardiovascular magnetic resonance imaging. JACC Cardiovasc Interv. 2008 Feb;1(1):44-53. doi: 10.1016/j.jcin.2007.11.003.
- Background: PubMed 24120215Pujadas S, Martin V, Rossello X, Carreras F, Barros A, Leta R, Alomar X, Cinca J, Sabate M, Pons-Llado G. Improvement of myocardial function and perfusion after successful percutaneous revascularization in patients with chronic total coronary occlusion. Int J Cardiol. 2013 Oct 30;169(2):147-52. doi: 10.1016/j.ijcard.2013.08.017. Epub 2013 Aug 15.
- Background: PubMed 25784515Christakopoulos GE, Christopoulos G, Carlino M, Jeroudi OM, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani DJ, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Meta-analysis of clinical outcomes of patients who underwent percutaneous coronary interventions for chronic total occlusions. Am J Cardiol. 2015 May 15;115(10):1367-75. doi: 10.1016/j.amjcard.2015.02.038. Epub 2015 Feb 18.
- Background: PubMed 25828320Hoebers LP, Claessen BE, Elias J, Dangas GD, Mehran R, Henriques JP. Meta-analysis on the impact of percutaneous coronary intervention of chronic total occlusions on left ventricular function and clinical outcome. Int J Cardiol. 2015;187:90-6. doi: 10.1016/j.ijcard.2015.03.164. Epub 2015 Mar 17.
- Background: PubMed 25700750Jang WJ, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-term survival benefit of revascularization compared with medical therapy in patients with coronary chronic total occlusion and well-developed collateral circulation. JACC Cardiovasc Interv. 2015 Feb;8(2):271-279. doi: 10.1016/j.jcin.2014.10.010.
- Background: PubMed 18682446Valenti R, Migliorini A, Signorini U, Vergara R, Parodi G, Carrabba N, Cerisano G, Antoniucci D. Impact of complete revascularization with percutaneous coronary intervention on survival in patients with at least one chronic total occlusion. Eur Heart J. 2008 Oct;29(19):2336-42. doi: 10.1093/eurheartj/ehn357. Epub 2008 Aug 5.
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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.
Massimo Lombardi, MD principal investigator
Policlinico San Donato
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 Coronary Chronic Total Occlusions, run by Ospedale San Donato 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 5 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 18 Mar 2021. 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 Massimo Lombardi, MD (+390252774376, massimo.lombardi@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mechanical improvement after PCI (time frame: 12 +/- 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 NCT03152825, which also lists 24 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 18 Mar 2021.