NCT01655043 is a Phase 2 clinical trial of Regadenoson in Myocardial Ischemia, sponsored by Northwestern University.

Who is sponsoring NCT01655043?

NCT01655043 is sponsored by Northwestern University.

What drugs are being tested in NCT01655043?

Interventions in NCT01655043: Regadenoson, gadofoveset trisodium.

What condition does NCT01655043 study?

NCT01655043 studies Myocardial Ischemia.

Is NCT01655043 still recruiting?

NCT01655043 is currently completed. Last updated 16 August 2019.

Are results published for NCT01655043?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-16 · How we verify

NCT01655043

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

Completed Phase 2 Results posted Last updated 16 August 2019

What this trial tests

Phase 2 trial testing Regadenoson in Myocardial Ischemia in 20 participants. Completed in 1 February 2014.

Timeline

1 September 2012

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	diagnostic
Enrollment	20
Start date	1 September 2012
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	1 location across United States

Drugs / interventions tested

Regadenoson — full drug profile →
gadofoveset trisodium — full drug profile →

Conditions studied

Myocardial Ischemia — all drugs for Myocardial Ischemia →

Sponsor

Northwestern University

Who can join

Adults 19 to 89, any sex, with Myocardial Ischemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Quantification of Myocardial Blood Volume
Time frame: outcome measured following single MRI scan
The investigators anticipated that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) would be capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and would be correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images

Sponsor's own description

Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Regadenoson

Trials testing the same drug.

NCT04316676 — The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI · NA · completed
NCT04606069 — Treat COVID-19 Patients With Regadenoson · Phase 1, PHASE2 · completed
NCT04521569 — Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System · EARLY_PHASE1 · completed
NCT03102125 — Allograft Dysfunction in Heart Transplant · Phase 4 · recruiting
NCT03505736 — Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer · completed

Other recruiting trials for Myocardial Ischemia

Currently open trials in the same condition.

NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
NCT07241572 — Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery · recruiting
NCT06681740 — Effectiveness of Inspiratory Muscle Training for People With Ischemic Heart Disease Revascularized by Percutaneous Trans · NA · recruiting
NCT06570759 — Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI · NA · active not recruiting

Other Northwestern University trials

Trials by the same sponsor.

NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies · Phase 1, PHASE2 · not yet recruiting
NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01655043 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 16 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01655043.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing