Coronary Artery DiseaseEarly Phase 1NCT03184155
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
A Early Phase 1 study testing Nicardipine and Sterile Saline in people with Coronary Artery Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Nicardipine and Sterile Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Dec 2026
- Phase
- Early Phase 1
- 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
Who may be able to join
- Consenting adults age > 18 years
- Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
- Target vessel lesion with > 50% stenosis treated by PCI
Who cannot join
- Patients presenting with ST elevation myocardial infarction
- Complete total occlusion of the vessel
- Unprotected left main disease
- Presentation with acute coronary syndrome and actively rising troponin
- Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
- Known hypersensitivity to nicardipine
Show all 11Show fewer
- Severe aortic stenosis
- Left Ventricular dysfunction with ejection fraction less than 30%
- Hemodynamically unstable defined as systolic blood pressure < 90 mmHg and not responding to IV fluids
- Significant chronic renal insufficiency (Glomerular filtration rate [GFR] <30)
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- Nicardipine, Sterile Saline
- Keywords
- Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease
- 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.
NicardipineDrug
200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI
Sterile SalineDrug
Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary Nicardipine | Experimental | 200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement. Receives: Drug: Nicardipine |
| Sterile Saline | Placebo comparator | Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement. Receives: Drug: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Index of Microcirculatory Resistance (IMR)
IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction
Measured: From the start of the PCI procedure to immediately following the PCI procedure
Secondary outcomes (4)
Post-Procedure myocardial Infarction (PMI)
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Measured: 6-8 hours post procedure
Post-Procedure myocardial Infarction (PMI)
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Measured: 12-18 hours post procedure
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Measured: 30 Days following procedure
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Measured: I year following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: This study was planned, but recruitment and enrollment never began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind, placebo controlled, study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Savage, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184155
- Sponsor's protocol ID
- 17D.172
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2017
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
- ClinicalTrials.gov ID
- NCT03184155
- Acronym / sponsor ID
- 17D.172
- Conditions
- Coronary Artery Disease
- Keywords
- Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was planned, but recruitment and enrollment never began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 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.
This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double blind, placebo controlled, study
| Arm | Type | Receives |
|---|---|---|
| Intracoronary Nicardipine | Experimental | Drug: Nicardipine200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement. |
| Sterile Saline | Placebo comparator | Drug: Sterile SalineInjection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consenting adults age > 18 years
- Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
- Target vessel lesion with > 50% stenosis treated by PCI
Key exclusion criteria (11 listed)
- Patients presenting with ST elevation myocardial infarction
- Complete total occlusion of the vessel
- Unprotected left main disease
- Presentation with acute coronary syndrome and actively rising troponin
- Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
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 |
|---|---|---|
| Nicardipine200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI | Drug | Intracoronary Nicardipine |
| Sterile SalineBolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI | Drug | Sterile Saline |
Primary outcome
Change in Index of Microcirculatory Resistance (IMR)
Time frame: From the start of the PCI procedure to immediately following the PCI procedure
IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction
4 secondary outcomes
Post-Procedure myocardial Infarction (PMI)
Time frame: 6-8 hours post procedure
Post-Procedure myocardial Infarction (PMI)
Time frame: 12-18 hours post procedure
Major Adverse Cardiac Event
Time frame: 30 Days following procedure
Major Adverse Cardiac Event
Time frame: I year following procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
Michael Savage, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicardipine and Sterile Saline in people with Coronary Artery Disease, run by Thomas Jefferson University at 1 site in United States.
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 11 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: withdrawn, as of the sponsor's last update on 26 Apr 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Index of Microcirculatory Resistance (IMR) (time frame: From the start of the PCI procedure to immediately following the PCI procedure). 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 26 Apr 2024.