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Eine Studie entspricht den Filterkriterien
Kartenansicht
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03537586 ist eine interventionsstudie zur Untersuchung von Koronare Mikrovaskuläre Krankheit, Ischämische Herzkrankheit, Myokardischämie und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 29. Juni 2018 und soll 206 Teilnehmer aufnehmen. Durchgeführt von NYU Langone Health ist der Abschluss für 30. Juni 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 28. November 2025 aktualisiert.
Kurzbeschreibung
Among patients with stable ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40% of these patients. However, the mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized as mechanisms of microvascular dysfunction. Investigators plan to evaluate association between platelet activity, inflammation, and coronary microvascular dysfunction in stable women referred for coronary angiography, and to identify non-invasive correlates of coronary microvascular dysfunction in these patients.
Ausführliche Beschreibung
The objectives of this study are to
- Investigate platelet activity and inflammation in patients with and without coronary microvascular disease who are referred for coronary angiography for the evaluation of stable ischemic heart disease and are found to have non-obstructuve epicardial CAD
- To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.
Offizieller Titel
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Erkrankungen
Koronare Mikrovaskuläre KrankheitIschämische HerzkrankheitMyokardischämiePublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- 18-00116
NCT-Nummer
Studienbeginn (tatsächlich)
2018-06-29
Zuletzt aktualisiert
2025-11-28
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
206
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Diagnostisch
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellNon-Obstructive CAD After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells. | Bivalirudin After diagnostic catheterization, intravenous bivalirudin (Angiomax) will be administered as part of the research procedure, and a 6F-guiding catheter without side holes will be used to engage the ostium of the coronary artery. Adenosine An intravenous infusion of adenosine (140 μg/kg/min) will be administered via a large peripheral or central vein to induce steady-state maximal hyperemia. Heparin Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist. Pressure-temperature Sensor Guidewire Abbott's Pressure Wire X will be used to measure fractional flow reserve (FFR), cardiac magnetic resonance (CMR) and Index of Microcirculatory Resistance (IMR) in the Left Anterior Descending (LAD) Artery and major epicardial coronary vessels associated with myocardial ischemia. Guiding Catheter Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR) | 12 Months | |
Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR) | 12 Months |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Adult women age ≥18 years referred for coronary angiography
- Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing
- Administration of aspirin therapy prior to cardiac catheterization
Pre-Cath Exclusion criteria:
- Active bleeding and/or bleeding diathesis
- Anemia (hemoglobin <9 mg/dl)
- Known thrombocytosis (platelet count >500,000)
- Know thrombocytopenia (platelet count <100,000)
- NSAIDs (e.g., ibuprofen, naproxen) within 3 days
- Platelet antagonists other than aspirin and thienopyridines, within 7 days
- Prior percutaneous coronary intervention or coronary artery bypass grafting
- Acute myocardial infarction within 3 months
- Severe valvular heart disease
- Cardiogenic shock or mechanical circulatory support
- New York Heart Association (NYHA) Functional Class III or IV heart failure
- Ejection Fraction <40%
- Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
- Pregnancy
- Contraindication to intravenous infusion of adenosine during coronary angiography, due to known hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease (severe asthma), second- or third-degree AV block (except in patients with a functioning artificial pacemaker), or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia,
Angiographic Exclusion criteria:
- Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
- Unfavorable coronary artery anatomy for guidewire positioning (as determined by the angiographer or PI)
NYU Langone HealthKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
New York
New York University School of Medicine, New York, New York, 10016, United States