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Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162902
First Posted: July 15, 2010
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
April 30, 2010
July 15, 2010
December 17, 2013
September 2013
January 2015   (Final data collection date for primary outcome measure)
Wall to lumen ratio of fundus vessel [ Time Frame: baseline, 9 months ]
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Same as current
Complete list of historical versions of study NCT01162902 on ClinicalTrials.gov Archive Site
  • lipid parameter [ Time Frame: baseline, 9 months ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
  • Serum markers of inflammation [ Time Frame: baseline, 9 months ]
    CRP
  • Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ]
    Measure of change of nitrate need
  • lipid parameter [ Time Frame: baseline, 9 months ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
  • Serum markers of inflammation [ Time Frame: baseline, 9 months ]
    Measurement of change in the level of IL-6, IL-10, CRP, and MMP-9
  • Exercise capacity [ Time Frame: baseline, 1 month, and 9 months ]
    Measurement of change of cardiopulmonary exercise capacity
  • Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ]
    Measure of change of nitrate need
Not Provided
Not Provided
 
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Stable Angina
  • Drug: Diltiazem treated group
    Diltiazem 180mg for 9 months
  • Drug: Bisoprolol treated group
    Bisoprolol 5mg for 9 months
  • Drug: Candesartan treated group
    Candesartan 32mg for 9 months
  • Experimental: Diltiazem treated group
    Diltiazem 180mg treated group
    Intervention: Drug: Diltiazem treated group
  • Active Comparator: Bisoprolol treated group
    Bisoprolol 5mg treated group
    Intervention: Drug: Bisoprolol treated group
  • Active Comparator: Candesartan treated group
    Candesartan 32mg treated group
    Intervention: Drug: Candesartan treated group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
December 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
  • Unstable Angina/NSTEMI patients who completed PCI for main lesions
  • Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

  • STEMI patients within one month
  • Variant Angina
  • Liver function abnormality or renal failure
  • History of Hypersensitivity to testing drugs
  • Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
  • Woman possible to be pregnant
  • Uncontrolled diabetes
  • Expected life span < one year
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01162902
ABC Trial
Yes
Not Provided
Not Provided
Hyo-Soo, Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP