Coronary Artery DiseaseNCT05415085
Culprit-first in Primary Percutaneous Coronary Intervention
A study testing Culprit-first PCI in people with Coronary Artery Disease and Ischemic Heart Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease, Myocardial Infarction
- What is being tested?
- Culprit-first PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2021to 13 Apr 2023
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with STEMI who are eligible for PPCI
Who cannot join
- Cardiac arrest
- Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory
- Prior coronary artery bypass grafting surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study
The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.
Read the detailed description
Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of <90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.
- Being tested
- Culprit-first PCI
- Keywords
- coronary artery disease, STEMI, primary PCI, door-to-balloon time
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culprit-first PCIProcedure or surgery
PCI to the culprit artery prior to the demonstration of the whole coronary tree.
| Study group | Role | What they receive |
|---|---|---|
| Culprit-first PCI | Experimental | In this arm, primary PCI with stent implantation will be performed prior to the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated first and the PCI will be performed. Receives: Procedure: Culprit-first PCI |
| Culprit-last PCI | No intervention | In this arm, primary PCI with stent implantation will be performed after the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated after the contralateral side and then PCI will be performed. This is the common approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle-to-balloon time of 10 minutes or less
Change in needle-to-balloon time in minutes
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Need for hemodynamic (mechanical/medical) support during PCI
Number of patients that needed mechanical support during PCI
Measured: through study completion, an average of 1 year
Need for respiratory support during PCI
Number of patients that needed respiratory support during PCI
Measured: through study completion, an average of 1 year
Rate of failed PCI
As determined by the operator
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 May 2021
- Primary completion30 Jun 2022
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nir Levi, Shaare Zedek Medical Center
- Investigators
- Nir Levi, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415085
- Sponsor's protocol ID
- 002
- Status last verified
- Oct 2023
- First submitted
- 27 Apr 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levi N, Wolff R, Jubeh R, Shuvy M, Steinmetz Y, Perel N, Maller T, Amsalem I, Hitter R, Asher E, Turyan A, Karmi M, Orlev A, Dratva D, Khoury Z, Hasin T, Wolak A, Glikson M, Dvir D. Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243729. doi: 10.1001/jamanetworkopen.2024.3729.
PubMed 38551563
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05415085
- Acronym / sponsor ID
- 002
- Keywords
- coronary artery disease, STEMI, primary PCI, door-to-balloon time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 10 Jun 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.
The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.
Detailed description
Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of <90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culprit-first PCI | Experimental | Procedure: Culprit-first PCIIn this arm, primary PCI with stent implantation will be performed prior to the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated first and the PCI will be performed. |
| Culprit-last PCI | No intervention | –In this arm, primary PCI with stent implantation will be performed after the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated after the contralateral side and then PCI will be performed. This is the common approach. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with STEMI who are eligible for PPCI
Key exclusion criteria (3 listed)
- Cardiac arrest
- Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory
- Prior coronary artery bypass grafting surgery
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 |
|---|---|---|
| Culprit-first PCIPCI to the culprit artery prior to the demonstration of the whole coronary tree. | Procedure or surgery | Culprit-first PCI |
Primary outcome
Needle-to-balloon time of 10 minutes or less
Time frame: through study completion, an average of 1 year
Change in needle-to-balloon time in minutes
3 secondary outcomes
Need for hemodynamic (mechanical/medical) support during PCI
Time frame: through study completion, an average of 1 year
Need for respiratory support during PCI
Time frame: through study completion, an average of 1 year
Rate of failed PCI
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 38551563Levi N, Wolff R, Jubeh R, Shuvy M, Steinmetz Y, Perel N, Maller T, Amsalem I, Hitter R, Asher E, Turyan A, Karmi M, Orlev A, Dratva D, Khoury Z, Hasin T, Wolak A, Glikson M, Dvir D. Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243729. doi: 10.1001/jamanetworkopen.2024.3729.
- Individual participant dataSharing planned: No
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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.
Nir Levi, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culprit-first PCI in people with Coronary Artery Disease and Ischemic Heart Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
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 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. 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 Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle-to-balloon time of 10 minutes or less (time frame: through study completion, an average of 1 year). 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 NCT05415085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.