Coronary Artery Disease
Conditions
Keywords
coronary artery disease, coffee, platelet aggregation, caffeine, aggregability
Brief summary
Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.
Detailed description
30 patients with coronary artery disease (proven by previous coronary angiography) will be selected at the Heart Institute (InCor USP) for the study. Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, one group will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days and another group will start with decaffeinated coffee followed by caffeinated. All participants will receive Nespresso coffee maker Essenza model. The coffee Nespresso blend voluto will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). The investigators will evaluate platelet aggregation by Multiplate® (ASPI, ADP and arachidonic acid) and by optical aggregometry (ADP and arachidonic acid).
Interventions
DIETARY_SUPPLEMENTCoffee
Participants will receive Nespresso coffee maker Essenza model. The coffee Nespresso blend voluto will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over).
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a prospective, open label, controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 80 years; * Coronary artery disease documented by coronary angiography; * Use of aspirin 100mg.
Exclusion criteria
* Serum creatinine dosage \> 2.5 mg/dl; * Hemoglobin \<12 g/% for men and \<11 g/% for women; * Platelets \<100,000 or \>400,000/mm3; * Leukocytosis \>12,000/mm3; * Fasting glycemia \>126mg/dl; * Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) with values above the upper limits of normality; * Consumption of more than 30 grams of alcohol per day; * Active smoking or ex-smoking for less than 2 years; * Use of P2Y12 inhibitor; * Ventricular dysfunction (left ventricular ejection fraction \<45%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation evaluated by Multiplate® ASPI | 8 weeks (±1) | Compare the inhibition of platelet aggregation evaluated by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid | 4 week (±1) | Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP and Arachidonic acid after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. |
| Platelet aggregation evaluated by Multiplate® ADP | 8 weeks (±1) | Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). |
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1 | 8 weeks (±1) | Compare platelet aggregability by optical aggregometry (ADP and arachidonic acid) after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). |
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) | 4 weeks (±1) | Compare the inhibition of platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Glycemia \>99mg/dl and no change in fasting glycemia |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With of Beta-blocker and without |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With statin and without |
| Delta change of platelet aggregation and Fraction of immature platelets (PFI) | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fraction of immature platelets (PFI) |
| Delta change of platelet aggregation and Sirtuins | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins |
| Delta change of platelet aggregation and Fasting glycemia | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia |
| Delta change of platelet aggregation and Glycated hemoglobin | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin |
| Delta change of platelet aggregation and Lipoprotein a | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipoprotein a - Lp(a) |
| Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Advanced glycation final product (RAGE) receiver |
| Delta change of platelet aggregation and Small-LDL | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL |
| Delta change of platelet aggregation and Lipid profile | 8 weeks (±1) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipid profile (total cholesterol, HDL \[high-density lipoprotein\], LDL \[low-density lipoprotein\], very low-density lipoprotein \[VLDL\] and triglycerides) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Elderly (≥65 years) and non-elderly |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Feminine and masculine genders |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction | 8 weeks (±1) | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Renal dysfunction (Creatinine \> 1.8mg/dl) and without renal dysfunction |
Countries
Brazil
Outcome results
None listed