Endothelial Function-guided Therapy Compared to Usual Care in Patients With NOCAD

Coronary Atherosclerosis Clinical Trial

— EndoGET  

Official title:

The Impact of Endothelial Function-guided Therapy Compared to Usual Care on Major Adverse Cardiovascular Events in Patients With Chest Pain and Non-obstructive Coronary Artery Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02313987
• Other study ID #: Endo-EndoGET-001
• Status: Withdrawn
• Phase: N/A
• First received: December 8, 2014
• Last updated: February 23, 2016
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2016
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionUnited States: Institutional Review BoardUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

The current study is designed to test the hypothesis that compared to conventional treatment; endothelial function-guided treatment reduces adverse cardiovascular events in patients with non-obstructive coronary artery disease documented at clinically indicated coronary angiography.

Description:

Subjects with chest pain and non-obstructive coronary artery disease (20-70% luminal diameter narrowing) documented by coronary angiograms will be enrolled in the study 2 - 30 days following the coronary angiograms. Only subjects who have signed an Informed Consent Form and meet all of the eligibility criteria will be qualified for enrollment.

Following the baseline EndoPAT testing subjects will be divided into two groups by their EndoPAT (EndoScore) results:

1. Group A - normal EndoScore: Logarithmic value of RHI (Ln_RHI) >0.7

2. Group B - abnormal EndoScore: Ln_RHI ≤ 0.7 The subjects of Group B will be randomized in 1:1 ratio (by envelopes with randomization numbers at each site) to Group B1 who will be treated conventionally i.e., "usual care" by the site study team; and Group B2 who will be treated with "enhanced care".

Staff prescribing treatment regime for subjects in group A and B1 ("usual care") along with the subjects in these groups, will be blinded to the EndoScore value.

Subjects of all groups will return for 4 follow-up visits: 180±14days, 360±14days, 720±14days and 1080±14days (study end).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Subjects with chest pain and non-obstructive coronary artery disease documented by coronary angiography with 20-70% luminal diameter stenosis that does not justify coronary revascularization

• Stable subjects without evidence of prior MI/CABG/PTCA.

• Age 20 to 79 years

• Ability to understand the study procedures and provide written informed consent

• Willingness and ability to comply with the study and its scheduled visits and study procedures

Exclusion Criteria:

• Age below 20 over 79 years

• Subjects with documented MI, PTCA or CABG

• Unstable angina

• Any lesion > 20% luminal narrowing in the left main coronary artery

• Congestive heart failure, NYHA class II - IV

• Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR calculated by MDRD) < 20 mL/min/1.73m2 at screening

• Uncontrolled hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) , 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening

• Symptomatic peripheral artery disease

• History of drug or alcohol abuse

• Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 times the ULN as determined by local laboratory analysis at screening

• Prior CVA or TIA

• Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma) with life expectancy of < 3 years

• Any planned surgery within 3 months after randomization

• Recipient of any major organ transplant (e.g., heart, lung, liver, bone marrow)

• Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years

• Known, concerning active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator

• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s). Special clearance can be obtained from the Steering Committee for subjects enrolled in studies not conflicting with this protocol

• History or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent, would pose a risk to the subject safety, or interfere with the study evaluation, procedures or completion

• Deformities of the digits of the upper extremities, which preclude adequate signal acquisition

• Subjects under the effect of short-acting NTG (3 hours washout period)

• Patient suffering from a medical condition prohibiting blood flow occlusion in both arms

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Meir Hospital	Kfar Saba
Israel	Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Time to the first occurrence of death, cardiovascular death, non-fatal myocardial infarction, stroke, transient ischemic attack, coronary revascularization, or hospitalization for congestive heart failure.	3 years	No
Secondary	Rehospitalization for chest pain		3 years	No
Secondary	quality of life questionnaire		3years	No
Secondary	time to the first occurrence of cardiovascular death		3 years	No
Secondary	myocardial infarction		3 years	No
Secondary	Stroke		3 years	No
Secondary	time to the first occurrence of death from any cause		3 years	No
Secondary	hospitalization for worsening heart failure		3 years	No
Secondary	time to the first occurrence of ischemic fatal or non-fatal stroke or transient ischemic attack.		3 years	No