Industry-sponsored studies
LOWER
LOWER: Lomitapide Observational Worldwide Evaluation Registry is a global, long-term, prospective, observational and treatment registry that VVMC Cardiovascular Research has been involved with this registry since 2016. LOMITAPIDE is a medication used to manage cardiovascular levels in adults with homozygous familial hypercholesterolemia (HoFH).
ORION-4
ORION-4 – The HPS-4/TIMI 65/ORION-4 Trial. This double-blinded, randomized, placebo-controlled trial assesses the effects of INCLISIRAN on clinical outcomes among people with atherosclerotic cardiovascular disease. The study aims to find out if a cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
EVOLVE-MI
EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized with Acute Myocardial Infarction.The primary objective of this study is to evaluate the effectiveness of early treatment with EVOLUCUMAB plus routine lipid management vs. routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI).
TAP-CHF Trial
TAP-CHF Trial: Sequential Randomized, Open Label, Multicenter Prospective Comparative Study to Evaluate the Treatment of Atrial Fibrillation in Preserved Cardiac Function Heart Failure – Phase 1. The purpose of the study is to compare two commonly-used and approved treatment strategies for atrial fibrillation. Patients will be randomly assigned to either 1) FDA approved oral medications to restore or control atrial fibrillation, OR, 2) catheter ablation. Both groups will have loop recorders implanted. Patient outcomes between the two groups will be compared in this nationwide study.
NAH-sponsored research
Monitor, Manage and Empower Pilot Study
Monitor, Manage, Empower Pilot Study: Improving Care to Cardiovascular Patients with Hypertension. This internally-supported pilot study analyzed patient health outcomes and quality of life when enrolled in a telehealth program called Remote Patient Monitoring. It sought to answer the question: Does enrolling patients with high blood pressure into NAH’s RPM Program lead to an improvement in blood pressure monitoring and in patients’ perception of their care? Publishable results are forthcoming.
Humanitarian use devices
HUDS are devices for which effectiveness has not been demonstrated, and therefore, IRB approval is required by the FDA.
JOSTENT GraftMaster Coronary Stent Graft
The GraftMaster is used in cardiovascular surgery for treatment of free perforations in native coronary vessels or saphenous vein bypass grafts >2.75 mm in diameter. This device is available at NAH in a non-research capacity, and is intended for treatment only.
PK Papyrus Covered Coronary Stent System
This stent system is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. This device is available at NAH in a non-research capacity, and is intended for treatment only.
Completed studies (no longer recruiting or in follow-up)
- ACCELERATE
- ARTEMIS
- Cardiovascular Inflammation Reduction Trial (CIRT)
- Clear Harmony
- Clear Harmony OLE
- CLEAR Outcomes
- Clear Wisdom
- CONNECT-HF
- Dal-GenE
- EUCLID
- HEART-FID
- REVEAL
- RE-DUAL PCI
- THEMIS