Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
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|ClinicalTrials.gov Identifier: NCT03184155|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2017
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Nicardipine Drug: Sterile Saline||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized double blind, placebo controlled, study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Intracoronary Nicardipine
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.
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
Placebo Comparator: Sterile Saline
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.
Drug: Sterile Saline
Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
- 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
- Post-Procedure myocardial Infarction (PMI) [ Time Frame: 6-8 hours post procedure ]PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
- Post-Procedure myocardial Infarction (PMI) [ Time Frame: 12-18 hours post procedure ]PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
- Major Adverse Cardiac Event [ Time Frame: 30 Days following procedure ]Incidence of myocardial infarction, rehospitalization, or mortality
- Major Adverse Cardiac Event [ Time Frame: I year following procedure ]Incidence of myocardial infarction, rehospitalization, or mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184155
|Contact: Melissa McCarey, MPHfirstname.lastname@example.org|
|Contact: Thomas Salerno, RNemail@example.com|
|Principal Investigator:||Michael Savage, MD||Thomas Jefferson University|