Ischemic Left Ventricle Systolic DysfunctionSTICOSNCT07133984
STICH3C Cardiac Magnetic Resonance Observational Study
An observational study of Ischemic Left Ventricle Systolic Dysfunction and Multivessel Coronary Artery Disease, run by Weill Medical College of Cornell University at 10 sites in 6 countries.
Trial summary
STICOS will test the hypothesis that residual jeopardized myocardium, late gadolinium enhancement, and non-ischemic substrate after revascularization is associated with postoperative adverse cardiovascular events such as heart failure , readmission, or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Left Ventricle Systolic Dysfunction, Multivessel Coronary Artery Disease
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- How many people
- 230 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Mar 2024to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diagnosed with iLVSD and multivessel coronary artery disease (CAD) undergoing revascularization (PCI or CABG)
Who may be able to join
- Men and women ≥ 18 years old
- LVEF ≤ 40% (quantified by echo, single-photon emission computed tomography [SPECT], or CMR within 2 months of enrollment)
- Prognostically important CAD: either multivessel CAD (triple vessel or double vessel CAD including left anterior descendant artery (LAD), significant coronary stenosis defined as ≥ 70% based on coronary angiography, fractional flow reserve (FFR) ≤ 0.80 or instantaneous wave-free ratio (iFR) ≤ 0.89) or left main disease (+/- other CAD) for which significant stenosis defined as > 50% based on coronary angiography, intravascular ultrasound (IVUS) minimum luminal area [MLA] value ≤ 6.0 mm2 (< 4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements.
- Either planned CABG/PCI within 3 months or CABG/PCI within the last 9 months.
Who cannot join
- Concomitant valve disease or other condition (e.g., LV aneurysm) requiring surgical repair or replacement
- Contraindication to CMR (i.e. magnetically activated materials), gadolinium, regadenoson/adenosine/dipyridamole
- Active neoplasm and/or severe end-organ dysfunction with expected life expectancy less than 5 years.
- -
Trial locations and contacts
10 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 6 countries
United States3 sites, 3 recruiting
- Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Sandhya Balaram, MD
- Recruiting
New York Presbyterian - Queens
Flushing, New York, 11355
Charles Mack, MD, 718-670-2400, cmack@med.cornell.edu
- Recruiting
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, 10022
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, 212 746 1812, mfg9004@med.cornell.edu
Canada3 sites, 3 recruiting
- Recruiting
Libin Cardiovascular Institute
Calgary, Alberta, T2N 1N4
Robert Miller, MD, 403 220 8191, Robert.miller@ahs.ca
- Recruiting
Universite Laval Quebec (CRIUCPQ) Canada
Québec
Pierre Voisine, pierre.voisine@chg.ulaval.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto
Stephen Fremes, Stephen.Fremes@sunnybrook.ca
Austria1 site, 1 recruiting
- Recruiting
MU Vienna Austria
Vienna
Sigrid Sandner, sigrid.sandner@meduniwien.ac.at
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Qiang Zhao, zq11607@rjh.com.cn
Poland1 site, 1 recruiting
- Recruiting
Zbigniew Religa Lower Silesian Heart Disease Centre - Medinet
Wroclaw
Sebastian Abdul-Hassan, +48 71 320 94 50, s.aboulhassan@gmail.com
Serbia1 site, 1 recruiting
- Recruiting
Dedinje Cardiovascular Institute
Belgrade
Milan Milojevic, m.milojevic@erasmusmc.nl
About this study
Official title: STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)
STICOS will test the hypothesis that residual jeopardized myocardium, late gadolinium enhancement, and non-ischemic substrate after revascularization is associated with postoperative adverse cardiovascular events such as heart failure , readmission, or death.
This study will look at whether certain heart tissue abnormalities seen on MRI scans can help predict serious health problems after heart procedures like stents or bypass surgery.
Read the detailed description
iLVSD (ischemic left ventricular dysfunction) is a leading cause of heart failure (HF) and death. It is widely treated via coronary revascularization despite limited understanding of determinants of revascularization response.
"Viability" imaging (to differentiate infarcted from salvageable myocardium) has been widely touted as an effective means to predict revascularization response. However prior multicenter trials have derived negative conclusions using heterogenous data with respect to both image modality and analysis.
Data by our investigators and others indicate that infarct transmurality on CMR strongly impacts remodeling and prognosis after coronary revascularization. The investigators have also developed new methods (dark-blood late gadolinium enhancement-CMR) to assess infarction and shown ischemia (hypoperfusion) and non-ischemic substrate on CMR to strongly impact LV remodeling. Despite conceptual rationale, utility of multiparametric CMR to elucidate mechanism and determinants of remodeling and differential outcomes after percutaneous and surgical revascularization of iLVSD has yet to be tested.
This prospective study will test the hypothesis that residual jeopardized (viable but hypoperfused) myocardium, LGE, and non-ischemic substrate after coronary revascularization (by PCI or CABG) is associated with postoperative adverse cardiovascular events
- Being tested
- Cardiac Magnetic Resonance Imaging
- Keywords
- iLVSD, CAD, Cardiac MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDiagnostic test
Also called CMR
Cardiac MRI, also known as cardiac magnetic resonance imaging, is a non-invasive imaging technique that uses strong magnetic fields and radio waves to produce detailed pictures of the heart and its surrounding structures
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with iLVSD and CAD undergoing revascularization. | Eligible patients will be approached by study team before PCI or CABG for consent to participate in the study. For patients in whom the treating physicians have requested or will request pre-procedure CMR for clinical reasons, consent to collect long-term clinical data will be requested. Eligible patients who meet inclusion criteria in whom clinical CMR is not planned, will be asked to undergo preoperative CMR with or without postoperative CMR and to be followed up for research purposes. Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Magnetic Resonance Imaging (CMR) Indices
The primary objective of this study is to relate Cardiac Magnetic Resonance Imaging (CMR) (infarction, perfusion, and nonischemic substrate) after iLVSD revascularization with long-term outcomes. This is measured by residual jeopardized (viable but hypoperfused) myocardium, LGE, and nonischemic substrate after PCI or CABG independently predict impaired clinical events such as HF readmission or death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Mar 2024
- Primary completionAug 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Left Ventricle Systolic DysfunctionStudies 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133984
- Sponsor's protocol ID
- 23-09026465
- Other IDs
- 1R01HL170566-01
- Acronym
- STICOS
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)
- ClinicalTrials.gov ID
- NCT07133984
- Acronym / sponsor ID
- STICOS / 23-09026465
- Keywords
- iLVSD, CAD, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STICOS will test the hypothesis that residual jeopardized myocardium, late gadolinium enhancement, and non-ischemic substrate after revascularization is associated with postoperative adverse cardiovascular events such as heart failure , readmission, or death.
This study will look at whether certain heart tissue abnormalities seen on MRI scans can help predict serious health problems after heart procedures like stents or bypass surgery.
Detailed description
iLVSD (ischemic left ventricular dysfunction) is a leading cause of heart failure (HF) and death. It is widely treated via coronary revascularization despite limited understanding of determinants of revascularization response.
"Viability" imaging (to differentiate infarcted from salvageable myocardium) has been widely touted as an effective means to predict revascularization response. However prior multicenter trials have derived negative conclusions using heterogenous data with respect to both image modality and analysis.
Data by our investigators and others indicate that infarct transmurality on CMR strongly impacts remodeling and prognosis after coronary revascularization. The investigators have also developed new methods (dark-blood late gadolinium enhancement-CMR) to assess infarction and shown ischemia (hypoperfusion) and non-ischemic substrate on CMR to strongly impact LV remodeling. Despite conceptual rationale, utility of multiparametric CMR to elucidate mechanism and determinants of remodeling and differential outcomes after percutaneous and surgical revascularization of iLVSD has yet to be tested.
This prospective study will test the hypothesis that residual jeopardized (viable but hypoperfused) myocardium, LGE, and non-ischemic substrate after coronary revascularization (by PCI or CABG) is associated with postoperative adverse cardiovascular events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with iLVSD and CAD undergoing revascularization. | – | Diagnostic Test: Cardiac Magnetic Resonance ImagingEligible patients will be approached by study team before PCI or CABG for consent to participate in the study. For patients in whom the treating physicians have requested or will request pre-procedure CMR for clinical reasons, consent to collect long-term clinical data will be requested. Eligible patients who meet inclusion criteria in whom clinical CMR is not planned, will be asked to undergo preoperative CMR with or without postoperative CMR and to be followed up for research purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with iLVSD and multivessel coronary artery disease (CAD) undergoing revascularization (PCI or CABG)
Key inclusion criteria (4 listed)
- Men and women ≥ 18 years old
- LVEF ≤ 40% (quantified by echo, single-photon emission computed tomography [SPECT], or CMR within 2 months of enrollment)
- Prognostically important CAD: either multivessel CAD (triple vessel or double vessel CAD including left anterior descendant artery (LAD), significant coronary stenosis defined as ≥ 70% based on coronary angiography, fractional flow reserve (FFR) ≤ 0.80 or instantaneous wave-free ratio (iFR) ≤ 0.89) or left main disease (+/- other CAD) for which significant stenosis defined as > 50% based on coronary angiography, intravascular ultrasound (IVUS) minimum luminal area [MLA] value ≤ 6.0 mm2 (< 4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements.
- Either planned CABG/PCI within 3 months or CABG/PCI within the last 9 months.
Key exclusion criteria (4 listed)
- Concomitant valve disease or other condition (e.g., LV aneurysm) requiring surgical repair or replacement
- Contraindication to CMR (i.e. magnetically activated materials), gadolinium, regadenoson/adenosine/dipyridamole
- Active neoplasm and/or severe end-organ dysfunction with expected life expectancy less than 5 years.
- -
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 |
|---|---|---|
| Cardiac Magnetic Resonance ImagingAlso: CMRCardiac MRI, also known as cardiac magnetic resonance imaging, is a non-invasive imaging technique that uses strong magnetic fields and radio waves to produce detailed pictures of the heart and its surrounding structures | Diagnostic test | Patients diagnosed with iLVSD and CAD undergoing revascularization. |
Primary outcome
Cardiac Magnetic Resonance Imaging (CMR) Indices
Time frame: 5 years
The primary objective of this study is to relate Cardiac Magnetic Resonance Imaging (CMR) (infarction, perfusion, and nonischemic substrate) after iLVSD revascularization with long-term outcomes. This is measured by residual jeopardized (viable but hypoperfused) myocardium, LGE, and nonischemic substrate after PCI or CABG independently predict impaired clinical events such as HF readmission or death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC principal investigator
Weill Medical College of Cornell University
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Left Ventricle Systolic Dysfunction and Multivessel Coronary Artery Disease, run by Weill Medical College of Cornell University at 10 sites in 6 countries.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Austria, China, Poland and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC (212.746.1812, sticos@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Magnetic Resonance Imaging (CMR) Indices (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.