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

NCT02313987 | Withdrawn DMC

• 1 other identifier: Endo-EndoGET-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Rehospitalization for chest pain

  3 years

• quality of life questionnaire

  3years

• time to the first occurrence of cardiovascular death

  3 years

• myocardial infarction

  3 years

• Stroke

  3 years

Study Arms (3)

A-Usual care- Standard care for NOCAD

Subjects with non obstructive CAD (20-70% luminal diameter stenosis) and normal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD

B1-Usual Care-Standard care for NOCAD

Subjects with non obstructive CAD (20-70% luminal diameter stenosis ) and abnormal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD. (Same care as Group A)

B2- Endothelial function guid care

Subjects with non obstructive CAD and abnormal Endothelial function as defined by EndoScore. These subjects will receive the an Endothelial Function-guided Therapy.

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with chest pain and non-obstructive coronary artery disease (20-70% diameter luminal narrowing) will be enrolled in the study 2-30 days following the coronary angiograms

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (2)

Meir Hospital

Kfar Saba, Israel

Location

Tel Hashomer

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amir Lerman, M.D; Prof

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

IL (2)