Microvascular Coronary Artery Disease Clinical Trial
Official title:
A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.
The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. Goals of this study are: 1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value. 2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow). 3. Time required for IMR measurements
The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators). Primary endpoint: 1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value. Secondary endpoints: 1. Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs. 2. Time required for IMR measurements 3. Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7 4. Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04069234 -
Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.
|
Phase 3 | |
| Recruiting |
NCT04560829 -
Additive Value of Physiology Coronary in Clinical Practice
|
||
| Recruiting |
NCT06080919 -
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).
|
N/A | |
| Terminated |
NCT04614467 -
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
|
Phase 2 | |
| Terminated |
NCT03236311 -
A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI
|
Phase 2 | |
| Recruiting |
NCT04541797 -
Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics With Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM)
|
N/A | |
| Recruiting |
NCT04598308 -
EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial
|
||
| Active, not recruiting |
NCT05197361 -
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
|
||
| Recruiting |
NCT04827498 -
Myocardial Ischemia Without Obstructive Coronary Stenoses
|
||
| Suspended |
NCT05756088 -
Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA
|
||
| Recruiting |
NCT06118450 -
Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients
|
||
| Recruiting |
NCT03217227 -
Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
|
||
| Completed |
NCT03462017 -
Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Not yet recruiting |
NCT06217120 -
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06316661 -
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
|
||
| Recruiting |
NCT04131075 -
The Cerebral-Coronary Connection (C3) Study
|
||
| Completed |
NCT04485234 -
Inclusive Invasive Physiological Assessment in Angina Syndromes Registry
|
||
| Completed |
NCT05471739 -
Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
|
||
| Completed |
NCT05406297 -
Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
|
||
| Not yet recruiting |
NCT06069401 -
The MASTER-PACT Study
|