Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926755
Other study ID # 2015-144
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2016
Est. completion date February 11, 2019

Study information

Verified date April 2019
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack, underwent successful opening of the artery with a stent, and have blockages greater than or equal to 50% in one or more of the other arteries to the heart; and to correlate this findings with cardiovascular outcomes at 1 year.


Description:

This is a prospective, open-label, single center registry. The study is designed to characterize plaque (i.e., assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages >50% in one or more of the other arteries in the heart. The procedure to do this will not be the same procedure that was done to open the artery that caused the heart attack, but will be scheduled 2-40 days after the first procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. The study will specifically evaluate the plaque characteristics in the arteries that didn't cause the heart attack, to see if these arteries have vulnerable plaque and is at risk for future heart attacks. If FFR shows abnormal blood flow, these arteries will be treated with stents. All patients will be followed for 12 months after the second catheterization. The purpose of the study is to determine how commonly vulnerable plaques are identified in patients with acute heart attacks, and how often these lead to future cardiac problems. Identification of plaque features that lead to future problems may allow the development of new medications and devices to prevent future heart attacks and death. These same plaque features are also thought to be operative in patients with blockages in the arteries to the brain, so this study may have important implications for stroke prevention as well. All patients will be considered eligible for participation if they had a recent acute heart attack resulting from complete occlusion of an artery to the heart, if the stent procedure to open the artery was successful, and if they have blockages > 50% in at least one other major heart artery. Patients will not be eligible for participation if they are too unstable with regard to heart, lung, brain, or kidney function, or if they have previous bypasses to the heart.

In selected patients, Coronary CT Angiography (CCTA) will be performed after the initial procedure to open the artery within 40 days. CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR.

The standard portion of the procedure includes the angiogram (X-ray pictures of the arteries), FFR (measurement of blood flow in the artery), IVUS and/or OCT (to assess the diameter of the artery and the size of the stent), medications, and all office visits. The research portion of the study requires all imaging studies be performed (NIRS IVUS, OCT, FFR) rather than just one or two of these imaging studies, and the CCTA.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 11, 2019
Est. primary completion date February 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

All patients with ST-elevation acute myocardial infarction (STEMI) and age > 18 years who meet all of the following criteria:

- Successful primary Percutaneous Intervention (PCI) of the Infarcted Related Artery (IRA) defined as final stenosis < 30%, Thrombolysis In Myocardial Infarction (TIMI) 3 flow

- At least 1 non-IRA with diameter stenosis = 50% and reference vessel diameter > 2mm

- None of the exclusion criteria

Exclusion Criteria:

Patients will be excluded if any of the following are present:

- Cardiogenic shock that persists > 24 hours after primary PCI

- Diffuse disease in non-IRA that precludes successful stenting

- Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m2 after hydration or optimization of Congestive Heart Failure (CHF) for cardiac death

- eGFR <60 cc/min/1.73 m2, will be in the MIAMI study for invasive imaging treatment group/cohort but will not get the coronary CCTA

- eGFR < 60 cc/min/1.73 m2, for coronary CCTA

- Active bleeding as defined as a fall in hemoglobin (HGB) concentration > 3 g/dL within 24 hours requiring blood transfusion, vasopressors to maintain Systolic BP > 100mmhg, or emergency surgical, endovascular, or endoscopic intervention.

- Mechanical complication of MI such as severe Mitral-Valve Regurgitation (MR), Ventricular Septal Defect (VSD) or pulmonary edema

- Uncontrolled Ventricular Tachycardia (VT) after primary PCI

- Inability to provide informed consent

- Ventilator-dependent respiratory failure

- Only non-IRA is a chronic total occlusion

- Non-IRA is in a Saphenous Vein Graft (SVG) or arterial graft

- Non-IRA is in the left main, ostial Left Anterior Descending (LAD), or ostial Left circumflex (LCX)

- Non-IRA includes a bifurcation with side branch > 2mm, medina 1-1-1

- Need for multivessel primary PCI during the index procedure

Study Design


Intervention

Procedure:
Coronary Angiography
Coronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA.

Locations

Country Name City State
United States William Beamont Hospital Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured during cardiac cath 2-40 days after the first cardiac catheterization procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. Repeat cardiac catheterization for Data Analysis Stenosis severity (using angiographic criteria defined as Diameter Stenosis (DS) > 70% and DS > 50%; 40 Days
Primary Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by IVUS Stenosis severity will be measured by IVUS criteria defined as minimal lumen cross sectional area (mCSA) < 4mm2, mCSA < 2.5mm2, plaque volume; and vulnerable plaque by IVUS-fibrous cap thickness. 40 Days
Primary Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by FFR cardiac catheterization with FFR criteria defined as FFR < 0.80; 40 Days
Primary Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by OCT Vulnerable plaque characteristics will be measured by OCT criteria - plaque ulceration, erosion, thrombus, fibrous cap thickness 2 - 40 Days
Primary Prevalence of hemodynamically-significant stenosis in non-infarct-related coronary arteries in STEMI patients as measured by CCTA Stenosis severity will be measured by CCTA criteria-Diameter Stenosis >70% 2 - 40 Days
Primary Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by NIRS Vulnerable plaque characteristics will be measure by NIRS criteria - Lipid Core Burden Index (LCBI) - 4mm > 300, Lipid Core Containing Plaque (LCP) distribution 2 - 40 Days
Secondary Incidence of cardiac events at 1-year after STEMI. Correlation between cardiovascular outcomes (MACE) at 1-year with measures of stenosis severity and presence of = 1 feature of vulnerable plaque. 1 Year
Secondary Correlation with coronary angiography with imagings findings and Coronary CT Angiography (CCTA) imaging findings. In selected patients, Coronary CT Angiography (CCTA) will be performed within 40 days after the initial procedure that opens the artery . CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR. 40 Days
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A